Month: April 2022

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Adagio Therapeutics annonce que l’ADG20 (adintrevimab) est le premier anticorps monoclonal à répondre aux critères d’évaluation primaires ayant une importance statistique dans l’ensemble de la prophylaxie pré et post-exposition et du traitement pour la COVID-19, et prévoit de demander une autorisation d’utilisation d’urgence aux États-Unis

Le risque de COVID-19 symptomatique a été réduit de 71 % par rapport au placebo dans la prophylaxie pré-exposition et de 75 % par rapport au placebo dans la prophylaxie post-exposition

Le risque d’hospitalisation ou de décès chez les participants atteints de COVID-19 légère à modérée a été réduit de 66 % par rapport au placebo dans la population d’analyse d’efficacité primaire, et de 77 % par rapport au placebo chez les participants ayant reçu un traitement dans les trois jours suivant l’apparition des symptômes

Résultats financiers pour l’ensemble de l’exercice et du quatrième trimestre 2021 ; 591 millions de dollars en liquidités et investissements devraient être suffisants pour financer les activités jusqu’au second semestre 2024

WALTHAM, Massachusetts, 31 mars 2022 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc. (Nasdaq : ADGI), une société biopharmaceutique de stade clinique axée sur la découverte, le développement et la commercialisation de solutions à base d’anticorps pour les maladies infectieuses, a indiqué que les principaux critères d’évaluation ont été atteints avec une signification statistique pour les trois indications dans les essais cliniques mondiaux de Phase 2/3 en cours de la Société évaluant son médicament expérimental adintrevimab (ADG20) en tant que prophylaxie pré-et post-exposition (EVADE) et traitement (STAMP) pour la COVID-19. EVADE et STAMP ont été principalement menés pendant une période où les variants pré-Omicron du SARS-CoV-2 étaient dominants. Suite à l’émergence du variant Omicron, dans une analyse exploratoire prédéfinie dans un sous-ensemble de la cohorte pré-exposition, une réduction cliniquement significative des cas de COVID-19 symptomatiques a été observée avec l’adintrevimab par rapport au placebo. À travers les deux essais, une seule administration intramusculaire (IM) de l’adintrevimab à la dose de 300 mg avait un profil d’innocuité similaire à celui du placebo. Sur la base de ces données, Adagio prévoit d’interagir avec la Food and Drug Administration (FDA) des États-Unis et de soumettre une demande d’autorisation d’utilisation d’urgence (EUA) au cours du deuxième trimestre 2022 pour l’adintrevimab à la fois pour la prévention et le traitement de la COVID-19.

En outre, Adagio a fourni une mise à jour sur son étude de Phase 1 en cours qui évalue l’adintrevimab à des doses plus élevées et sur les activités de recherche liées à la restructuration de l’adintrevimab et à l’identification de nouveaux anticorps pour traiter potentiellement la COVID-19 et d’autres virus.

« La COVID-19 continue de poser des défis importants à l’échelle mondiale, car la perte d’immunité associée à l’émergence de variants résistants a conduit à des vagues continues de maladies. Nous pensons qu’une suite d’options, couvrant la prophylaxie et le traitement, est nécessaire pour traiter efficacement ce virus alors qu’il continue d’évoluer, et ces données nous donnent confiance dans le rôle potentiel que l’adintrevimab peut jouer dans les arsenaux des médecins », a déclaré David Hering, MBA, directeur général et président-directeur général par intérim d’Adagio. « Sur la base des données d’EVADE et de STAMP, y compris les impacts observés dans les analyses préliminaires des participants enrôlés après l’émergence du variant Omicron, notre équipe entame des discussions avec la FDA et prépare une soumission EUA pour l’adintrevimab. Avec plus d’un million de doses d’adintrevimab sécurisées pour 2022 et une position financière solide qui devrait nous mener jusqu’au second semestre 2024, nous sommes optimistes quant à la voie à suivre et à l’impact que l’adintrevimab pourrait avoir pour de nombreuses personnes à travers le monde, en particulier celles à haut risque avec des co-morbidités, qui continuent d’avoir besoin d’options. »

Michael Ison, M.D., M.S., professeur de médecine dans la Division des maladies infectieuses, et de chirurgie dans la Division des transplantations d’organes de l’École de médecine Feinberg de l’Université North Western, a ajouté : « Les données irréfutables générées sur l’adintrevimab dans les deux essais cliniques d’Adagio représentent une étape importante dans la lutte contre la poursuite de la pandémie de COVID-19. Je suis particulièrement encouragé par l’effet de traitement constant observé dans les trois contextes cliniques et les sous-populations de patients, ainsi que par le profil d’innocuité favorable, avec seulement une dose unique et une administration IM pratique pour tous les patients. La réduction des risques dans le cadre de la prophylaxie post-exposition quel que soit le statut sérologique se traduit par une utilisation dans le monde réel lorsque les cliniciens ne connaissent peut-être pas le statut vaccinal ou infectieux antérieur de leurs patients. Dans l’essai STAMP, l’adintrevimab a montré une prévention des hospitalisations et des décès face au variant ” à risque le plus élevé ” (Delta) à ce jour. »

Données préliminaires d’EVADE
EVADE est un essai clinique mondial, multicentrique, en double aveugle et contrôlé par placebo de Phase 2/3 évaluant l’adintrevimab à la dose IM de 300 mg dans deux cohortes indépendantes pour la prévention de la COVID-19. L’étude comprend une cohorte de prophylaxie pré-exposition (PrEP) et une cohorte de prophylaxie post-exposition (PPE). La population étudiée est composée d’adultes et d’adolescents exposés à l’infection par le SARS-CoV-2 en raison de l’exposition récente signalée ou dont les circonstances les ont exposés à un risque accru de contracter l’infection par le SARS-CoV-2 et de développer une COVID-19 symptomatique.

Dans l’analyse d’efficacité primaire de la cohorte PrEP, l’adintrevimab a été associé à une incidence plus faible de la COVID-19 symptomatique par rapport au placebo jusqu’au troisième mois ou à l’émergence d’Omicron, selon l’éventualité qui vient en premier lieu (12/730, 1,6 % vs 40/703, 5,7 %, respectivement). La différence de risque normalisée était de -4,0 % (95 % CI –6,0, -2,1 ; p < 0,0001), démontrant une réduction du risque relatif de 71 % en faveur de l’adintrevimab jusqu’à trois mois. Il y a eu cinq (0,7 %) hospitalisations liées à la COVID-19 dans le groupe placebo par rapport à aucune hospitalisation dans le groupe adintrevimab. Dans une analyse exploratoire prédéfinie de la cohorte PrEP, qui comprenait 402 participants (196 et 206 dans les groupes de l’adintrevimab et du placebo, respectivement) suite à l’émergence d’Omicron (BA.1), une réduction cliniquement significative des cas de COVID-19 symptomatique a été observée avec l’adintrevimab, par rapport au placebo. L’adintrevimab a été associé à une réduction relative des risques de 59 % et de 47 % avec une durée médiane de suivi de 56 et 77 jours, respectivement (valeur nominale p < 0,05).

Dans l’analyse d’efficacité primaire de la cohorte PEP, l’adintrevimab a atteint une importance statistique et a été associé à une incidence plus faible de la COVID-19 symptomatique jusqu’au jour 28 par rapport au placebo (3/173, 1,7 % contre 12/175, 6,9 % respectivement). La différence de risque normalisée était de -4,9 % (95 % CI : -8,8, -1,0 ; p=0,0135), démontrant une réduction du risque relatif de 75 % en faveur de l’adintrevimab pendant 28 jours. Il y a eu deux (1,1 %) hospitalisations liées à la COVID-19 dans le groupe placebo par rapport à aucune hospitalisation dans le groupe adintrevimab.

Dans les cohortes EVADE, sur 1 239 participants traités par adintrevimab avec une plage médiane de suivi de 140 jours pour la cohorte PrEP et de 126 jours pour la cohorte PPE au 2 mars 2022, date limite de collecte des données, le profil d’innocuité était similaire à celui du placebo. L’incidence des effets indésirables (AE), y compris les effets indésirables graves (SAE), était similaire entre les groupes adintrevimab et placebo. Aucun SAE lié aux médicaments, décès compris, n’a été signalé. Les effets indésirables les plus fréquemment signalés étaient des réactions sur le site d’injection, dont la majorité étaient de gravité légère ou modérée et se produisaient avec une fréquence similaire dans les deux groupes.

Données préliminaires de STAMP
STAMP est un essai clinique mondial, multicentrique, en double aveugle et contrôlé par placebo de Phase 2/3 évaluant l’adintrevimab à la dose IM de 300 mg chez les patients atteints d’une forme légère à modérée de COVID-19 présentant un risque élevé de progression de la maladie. L’adintrevimab a été associé à une incidence plus faible statistiquement significative d’hospitalisation liée à la COVID-19 ou de décès toutes causes confondues jusqu’au jour 29 par rapport au placebo (8/169, 4,7 % vs 23/167, 13,8 %), avec une différence de risque normalisée de -8,6 % (95 % CI : -14,65, -2,57 ; p=0,0052), démontrant une réduction du risque relatif de 66 % en faveur de l’adintrevimab. Il y a eu un décès (0,6 %) dans le groupe adintrevimab, contre six (3,6 %) dans le groupe placebo jusqu’au jour 29. Chez les patients traités dans les trois jours suivant l’apparition des symptômes (adintrevimab n=91, placebo n=85), l’adintrevimab a réduit de 77 % le risque d’hospitalisation ou de décès dus à la COVID-19 par rapport au placebo. STAMP a enrôlé 63 participants (29 dans le groupe adintrevimab et 34 dans le groupe placebo) présentant une infection par la COVID-19 avec le variant Omicron du SARS-CoV-2. Il y a eu deux événements d’hospitalisation liée à la COVID-19 et aucun décès jusqu’au jour 29 parmi les patients atteints du variant Omicron, et les deux événements d’hospitalisation se sont produits dans le groupe placebo.

Dans STAMP, sur 192 participants traités par adintrevimab avec un suivi médian de 73 jours dans le groupe adintrevimab au 2 février 2022, date limite de collecte des données, l’incidence des AE, y compris les SAE, était plus faible dans le groupe adintrevimab. Aucun SAE lié aux médicaments, décès compris, n’a été signalé. Les effets indésirables les plus fréquemment signalés étaient les réactions sur le site d’injection, qui étaient toutes de gravité légère ou modérée et se produisaient avec une fréquence similaire dans les deux groupes.

« Au nom de l’ensemble de l’équipe d’Adagio, j’aimerais remercier les nombreux chercheurs, équipes cliniques et, surtout, les patients, les familles et les soignants pour leur participation à nos essais cliniques. Nous sommes encouragés par ces données et sommes impatients de soumettre une EUA et de discuter de ces résultats avec la FDA et les autres autorités de réglementation. En outre, nous poursuivons nos efforts de recherche pour améliorer l’activité de l’adintrevimab contre Omicron et identifier les anticorps ciblant de nouveaux domaines, ce qui fournira des produits candidats supplémentaires potentiels à intégrer au développement clinique. Collectivement, ces efforts démontrent la capacité de notre plateforme et de notre expertise à découvrir et concevoir de nouveaux anticorps, et à exécuter des essais cliniques mondiaux, afin de traiter potentiellement les maladies infectieuses », a déclaré Ellie Hershberger, Pharm.D., directrice du développement chez Adagio.

Mises à jour supplémentaires en matière de développement et de recherche
Adagio continue de tirer parti de sa plateforme et de son expertise en déployant de nombreux efforts pour lutter contre la COVID-19, d’autres coronavirus, la grippe et d’autres maladies infectieuses, y compris :

  • Faire progresser un essai de Phase 1 chez des volontaires en bonne santé pour évaluer la pharmacocinétique et l’innocuité de doses supplémentaires plus élevées d’adintrevimab pour compléter les données générées à ce jour, qui ont évalué les doses jusqu’à 600 mg en IM. Les données préliminaires d’innocuité dans les deux semaines suivant le dosage suggèrent un profil d’innocuité favorable à la dose de 1 200 mg administrée par injection IM ou par voie intraveineuse (IV).
  • Les efforts en cours visent à modifier l’adintrevimab pour améliorer la liaison avec les sous-variants Omicron (BA.1 et BA.2) afin d’augmenter le pouvoir de neutralisation tout en conservant la large neutralisation observée in vitro contre d’autres variants préoccupants du SARS-CoV-2. Les variants repensés de l’ADG20 montrent une amélioration de la liaison plus de 100 fois supérieure et une activité neutralisante jusqu’à 40 fois plus forte contre le variant Omicron BA.1 tout en maintenant l’activité par rapport à tous les autres variants préoccupants testés à ce jour.
  • Les efforts de découverte en cours visent à évaluer d’autres anticorps monoclonaux de la bibliothèque exclusive d’anticorps SARS-CoV-2 de la Société, précédemment isolés pour l’étendue et la puissance de neutralisation, et qui pourraient être développés en tant que traitement autonome ou association médicamenteuse. De nouveaux anticorps isolés des donneurs d’infection Omicron ont montré une activité in vitro contre le virus SARS 2003 et tous les variants préoccupants du SARS-CoV-2 testés à ce jour, y compris les variants BA.1 et BA.2.
  • Des efforts de découverte sont en cours pour identifier de nouveaux anticorps largement neutralisants qui ciblent les épitopes à la fois à l’intérieur et à l’extérieur du domaine de liaison du récepteur du SARS-CoV-2 et des anticorps neutralisants du virus pan betacoronavirus.

Résultats financiers du quatrième trimestre et de l’ensemble de l’exercice 2021

  • Situation de trésorerie et directives financières : la trésorerie, les équivalents de trésorerie et les titres négociables s’élevaient à 591,4 millions de dollars au 31 décembre 2021. Selon les plans d’exploitation actuels, Adagio s’attend à ce que sa trésorerie, ses équivalents de trésorerie et ses titres négociables existants permettent à la Société de financer ses dépenses d’exploitation et ses besoins en dépenses d’investissement jusqu’au second semestre 2024.
  • Dépenses de R&D : les dépenses de Recherche et Développement (R&D), y compris les dépenses de recherche et développement en cours, se sont élevées à 68,4 millions de dollars pour le trimestre clos au 31 décembre 2021, et à 190,4 millions de dollars pour l’exercice clos au 31 décembre 2021.
  • Frais généraux et administratifs : les frais de vente, généraux et administratifs (SG&A) se sont élevés à 14,7 millions de dollars pour le trimestre clos au 31 décembre 2021, et à 36,5 millions de dollars pour l’exercice clos au 31 décembre 2021.
  • Perte nette : la perte nette s’est élevée à 83,0 millions de dollars, soit une perte nette de base et diluée de 0,77 $ par action, pour le trimestre clos au 31 décembre 2021, et à 226,8 millions de dollars, soit une perte nette de base et diluée de 5,32 $ par action, pour l’exercice clos au 31 décembre 2021.

À propos de l’adintrevimab
L’adintrevimab (ADG20), le principal produit candidat d’Adagio, est conçu pour être un anticorps puissant et largement neutralisant à la fois pour la prévention et le traitement de la COVID-19, y compris la maladie causée par la plupart des variants, en tant qu’agent soit unique, soit combiné. L’adintrevimab est en cours d’évaluation dans le cadre de deux essais cliniques de Phase 2/3 distincts : l’essai EVADE pour la prévention de la COVID-19 à la fois dans les environnements post-exposition et pré-exposition, et l’essai STAMP pour le traitement de la COVID-19. Les données préliminaires issues de ces essais ont démontré que dans la population pré-Omicron, l’adintrevimab a atteint les critères d’évaluation primaires pour les trois indications, démontrant une efficacité statistiquement significative et cliniquement pertinente. À travers chacun des essais, l’administration intramusculaire (IM) de l’adintrevimab à la dose de 300 mg avait un profil d’innocuité similaire à celui du placebo. L’adintrevimab est également examiné dans une étude de Phase 1 visant à évaluer l’innocuité et la pharmacocinétique à des doses plus élevées, et à la date limite intermédiaire de collecte des données, aucun(e) événement indésirable lié aux médicaments, événement indésirable grave, réaction du site d’injection ou réaction d’hypersensibilité n’a été signalé(e) à tous les niveaux de dose évalués. L’adintrevimab est un anticorps monoclonal expérimental qui n’est approuvé pour une utilisation dans aucun pays. L’innocuité et l’efficacité de l’adintrevimab n’ont pas été établies.

À propos d’Adagio Therapeutics
Adagio (Nasdaq : ADGI) est une société biopharmaceutique au stade clinique axée sur la découverte, le développement et la commercialisation de produits différenciés pour la prévention et le traitements des maladies infectieuses. La Société développe actuellement son principal produit candidat, l’adintrevimab, pour la prévention et le traitement de la COVID-19, la maladie causée par le virus SARS-CoV-2 et ses variants. Au-delà de la COVID-19, Adagio tire parti de solides capacités de découverte et de développement d’anticorps qui ont permis d’accélérer la progression de l’adintrevimab dans des essais cliniques afin de développer des options thérapeutiques ou préventives pour d’autres maladies infectieuses, telles que d’autres coronavirus et la grippe. L’adintrevimab est un anticorps monoclonal expérimental qui n’est approuvé pour une utilisation dans aucun pays. L’innocuité et l’efficacité de l’adintrevimab n’ont pas été établies. Pour plus d’informations, rendez-vous sur le site www.adagiotx.com.

Énoncés prospectifs
Le présent communiqué de presse contient des énoncés prospectifs au sens de la loi Private Securities Litigation Reform (Réforme sur la résolution des litiges portant sur des titres privés) de 1995. Des mots tels que « anticipe », « croit », « pourrait », « s’attend à », « a l’intention de », « potentiel », « prévoit » et « à l’avenir » ou des expressions similaires sont destinés à identifier des énoncés prospectifs. Les énoncés prospectifs comprennent des énoncés concernant, entre autres choses, le calendrier, les progrès et les résultats de nos études précliniques et essais cliniques sur l’adintrevimab, l’examen et l’analyse des données issues de nos essais en cours et de leur calendrier, le lancement, la modification et l’achèvement des études ou des essais et les travaux préparatoires connexes, et nos programmes de recherche et de développement ; nos plans relatifs à la collaboration avec les autorités de réglementation, y compris le calendrier des soumissions ou des demandes réglementaires ; notre recherche d’autres stratégies visant à élargir notre portefeuille de mAbs au SARS-CoV-2 afin de répondre aux autres variants préoccupants du SARS-CoV-2, y compris les variants Delta et Omicron ; nos efforts de découverte pour identifier de nouveaux anticorps largement neutralisants qui ciblent des épitopes distincts à l’intérieur et à l’extérieur du domaine de liaison du récepteur du SARS-CoV-2 et d’autres coronavirus bêta ; notre flux de trésorerie attendu ; et d’autres énoncés qui ne sont pas des faits historiques. Nous ne pourrons peut-être pas réaliser les plans, les intentions ou les attentes divulgués dans nos énoncés prospectifs et vous ne devez pas vous fier indûment à nos énoncés prospectifs. Ces énoncés prospectifs impliquent des risques et des incertitudes qui pourraient amener nos résultats réels à différer sensiblement des résultats décrits ou sous-entendus par les énoncés prospectifs, y compris, sans limitation, les impacts de la pandémie de COVID-19 sur nos activités et celles de nos collaborateurs, nos essais cliniques et notre situation financière, les données d’innocuité ou d’efficacité inattendues observées lors d’études précliniques ou d’essais cliniques, le caractère prévisible du succès clinique de l’adintrevimab sur la base de l’activité neutralisante dans des essais précliniques, la variabilité des résultats dans les modèles utilisés pour prévoir l’activité contre les variants préoccupants du SARS-CoV-2, les taux d’activation ou de recrutement de sites d’essai clinique qui sont inférieurs aux prévisions, l’évolution de la concurrence attendue ou existante, les changements dans l’environnement réglementaire, et les incertitudes et le calendrier du processus d’approbation réglementaire, y compris les résultats de nos discussions avec les autorités règlementaires concernant nos essais cliniques de Phase 2/3 et le résultat de toute soumission de demande d’utilisation d’urgence. D’autres facteurs pouvant causer une différence matérielle entre nos résultats réels et ceux exprimés ou sous-entendus dans les énoncés prospectifs de ce communiqué de presse sont décrits sous la rubrique « Risk Factors » (Facteurs de risque) du rapport trimestriel d’Adagio sur le formulaire 10-Q pour le trimestre clos le 30 septembre 2021 déposé auprès de la Securities and Exchange Commission (la « SEC » ou Commission des valeurs mobilières des États-Unis) et dans nos autres documents déposés auprès de la SEC, et dans les futurs rapports qu’Adagio déposera auprès de la SEC. De tels risques peuvent être amplifiés par les impacts de la pandémie de COVID-19.  Les énoncés prospectifs contenus dans le présent communiqué de presse sont formulés à cette date, et Adagio décline toute obligation de mettre à jour ces informations sauf si la loi en vigueur l’exige.

Contact
Contact auprès des médias :
Dan Budwick, 1AB
dan@1abmedia.com

Contact auprès des investisseurs :
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.
BILANS CONSOLIDÉS
(NON VÉRIFIÉS)
(en milliers, à l’exception des actions et des montants par action)

December 31,
2021 2020
Assets
Current assets:
Cash and cash equivalents $ 542,224 $ 114,988
Marketable securities 49,194 —
Prepaid expenses and other current assets 25,293 2,394
Total current assets 616,711 117,382
Property and equipment, net 83 —
Other non-current assets 3,297 —
Total assets $ 620,091 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable $ 5,783 $ 8,153
Accrued expenses 56,277 4,919
Total current liabilities 62,060 13,072
Early-exercise liability 6 11
Other non-current liabilities 6 —
Total liabilities 62,072 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C), $0.0001 par value; no shares authorized, issued and outstanding at December 31, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $0 and $169,900 at December 31, 2021 and December 31, 2020, respectively — 169,548
Stockholders’ equity (deficit):
Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at December 31 2021; no shares authorized, issued and outstanding at December 31, 2020 — —
Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 111,251,660 shares issued and 110,782,909 shares outstanding at December 31, 2021; 150,000,000 shares authorized, 28,193,240 shares
issued and 5,593,240 shares outstanding as of December 31, 2020		 11 1
Treasury stock, at cost; 468,751 shares and 22,600,000 shares at December 31, 2021 and December 31, 2020, respectively — (85 )
Additional paid-in capital 850,125 154
Accumulated other comprehensive loss (8 ) —
Accumulated deficit (292,109 ) (65,319 )
Total stockholders’ equity (deficit) 558,019 (65,249 )
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 620,091 $ 117,382

ADAGIO THERAPEUTICS, INC.
ÉTATS CONSOLIDÉS DES OPÉRATIONS ET PERTES GLOBALES
(NON VÉRIFIÉS)
(en milliers, à l’exception des actions et des montants par action)

Year Ended
December 31, 2021		 Period from
June 3, 2020
(Inception) to
December 31, 2020
Operating expenses:
Research and development(1) $ 182,891 $ 21,992
Acquired in-process research and development(2) 7,500 40,125
Selling, general and administrative 36,517 3,210
Total operating expenses 226,908 65,327
Loss from operations (226,908 ) (65,327 )
Other income (expense):
Other income (expense), net 118 8
Total other income (expense), net 118 8
Net loss (226,790 ) (65,319 )
Other comprehensive income (loss):
Unrealized loss on available-for-sale securities, net of tax (8 ) —
Comprehensive loss $ (226,798 ) $ (65,319 )
Net loss per share attributable to common stockholders, basic and diluted $ (5.32 ) $ (18.10 )
Weighted-average common shares outstanding, basic and diluted 42,621,265 3,608,491

(1) Comprend des montants de parties liées de 4 150 dollars pour l’exercice clos au 31 décembre 2021 et de 595 dollars pour la période allant du 3 juin 2020 (création) au 31 décembre 2020.
(2) Comprend des montants de parties liées de 7 500 dollars pour l’exercice clos au 31 décembre 2021 et de 39 915 dollars pour la période allant du 3 juin 2020 (création) au 31 décembre 2020.

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Adagio Therapeutics anuncia que o ADG20 (adintrevimabe) é o primeiro anticorpo monoclonal a atingir a meta final principal com significância estatística na profilaxia e tratamento pré e pós-exposição à COVID-19, e que pretende solicitar autorização de uso de emergência nos EUA

O risco de COVID-19 sintomático foi reduzido em 71% em comparação com placebo na profilaxia pré-exposição e 75% em comparação com placebo na profilaxia pós-exposição

O risco de hospitalização ou morte dos participantes com COVID-19 leve a moderada foi reduzido em 66% em comparação com o placebo na população de análise de eficácia primária e em 77% em comparação com o placebo nos participantes que receberam tratamento dentro de três dias após o início dos sintomas

Resultados financeiros para o ano e quarto trimestre de 2021: US $ 591 milhões em caixa e investimentos que devem ser suficientes para financiar as operações até o segundo semestre de 2024

WALTHAM, Mass., March 31, 2022 (GLOBE NEWSWIRE) — A Adagio Therapeutics, Inc. (Nasdaq: ADGI), uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções com base em anticorpos para doenças infecciosas, divulgou o alcance da meta final principal com significância estatística para todas as três indicações nos ensaios clínicos globais de Fase 2/3 em andamento da empresa do seu medicamento investigacional adintrevimabe (ADG20) como uma profilaxia (EVADE) e tratamento (STAMP) pré e pós-exposição da COVID-19. O EVADE e STAMP foram conduzidos principalmente durante um período em que as variantes pré-Omicron SARS-CoV-2 estavam dominantes. Após o surgimento da variante Omicron, em uma análise exploratória pré-especificada em um subconjunto da coorte de pré-exposição, foi observada uma redução clinicamente significativa nos casos de COVID-19 sintomática com o adintrevimabe em comparação com o placebo. Em ambos os ensaios, uma única aplicação intramuscular (IM) do adintrevimabe de 300 mg teve um perfil de segurança semelhante ao do placebo. Com base nesses dados, a Adagio pretende solicitar da Food and Drug Administration dos EUA (FDA) um pedido de Autorização de Uso de Emergência (Emergency Use Authorization – EUA) no segundo trimestre de 2022 para o adintrevimabe para a prevenção e tratamento da COVID-19.

Além disso, a Adagio forneceu uma atualização sobre seu estudo de Fase 1 em andamento avaliando o adintrevimabe em doses mais altas e sobre as atividades de pesquisa relacionadas à reengenharia do adintrevimabe e a identificação de novos anticorpos para abordar potencialmente a COVID-19 e outros vírus.

“A COVID-19 continua a apresentar desafios significativos em todo o mundo, uma vez que o declínio da imunidade, juntamente com o surgimento de variantes resistentes, levou a ondas contínuas da doença. Acreditamos que um conjunto de opções – abrangendo a profilaxia e o tratamento – seja necessário para abordar efetivamente esse vírus à medida que ele continua a evoluir, e esses dados nos dão confiança no papel potencial que o adintrevimabe pode desempenhar nos arsenais dos médicos”, disse David Hering, MBA, diretor executivo interino e diretor de operações da Adagio. “Com base nos dados do EVADE e STAMP, incluindo os impactos observados nas análises preliminares dos participantes inscritos após o surgimento da variante Omicron, nossa equipe está iniciando discussões com o FDA e preparando um pedido de aprovação para o adintrevimabe nos EUA. Com mais de um milhão de doses de adintrevimabe garantidas para 2022 e uma sólida posição financeira esperada para nos levar até o segundo semestre de 2024, estamos otimistas sobre o caminho a seguir e o impacto que o adintrevimabe poderia ter para as muitas pessoas em todo o mundo, particularmente aquelas em alto risco com comorbidades, que continuam a precisar de mais alternativas.”

Michael Ison, M.D., M.S., professor de Medicina na Divisão de Doenças Infecciosas e de Cirurgia na Divisão de Transplante de Órgãos da Northwestern University Feinberg School of Medicine, acrescentou: “os dados convincentes gerados sobre o adintrevimabe em ambos os ensaios clínicos da Adagio representam um passo importante para abordar ainda mais a continuação da pandemia da COVID-19. Estou particularmente encorajado pelo efeito consistente do tratamento observado em todos os três contextos clínicos e subpopulações de pacientes, e pelo perfil de segurança favorável, com apenas uma dose e aplicação IM conveniente para todos os pacientes. A redução do risco no cenário de profilaxia pós-exposição, independentemente do sorostatus, se traduz em uso no mundo real quando os médicos possam não ter conhecimento do status de vacinação ou infecção anterior dos seus pacientes. No estudo STAMP, o adintrevimabe mostrou prevenção de hospitalização e morte diante da variante de ‘maior risco‘ (Delta) até o momento.”

EVADE – Dados Preliminares
EVADE é um ensaio clínico global, multicêntrico, duplo-cego, controlado por placebo de Fase 2/3 que avalia o adintrevimabe na dose de 300 mg IM em duas coortes independentes para a prevenção da COVID-19. O estudo inclui uma coorte de profilaxia pré-exposição (PrEP) e uma coorte de profilaxia pós-exposição (PEP). A população do estudo é composta por adultos e adolescentes em risco de infecção por SARS-CoV-2 devido à exposição recente relatada ou cujas circunstâncias os colocaram em risco aumentado de adquirir infecção por SARS-CoV-2 e desenvolver COVID-19 sintomático.

Na análise de eficácia primária da coorte PrEP, o adintrevimabe foi associado a uma incidência menor de COVID-19 sintomática em comparação com o placebo até o terceiro mês ou o surgimento do Omicron, o que ocorrer primeiro (12/730, 1,6% vs. 40/703, 5,7%, respectivamente). A diferença de risco padronizada foi de -4,0% (IC95% -6,0; -2,1; p <0,0001), demonstrando uma redução de 71% no risco relativo a favor do adintrevimabe ao longo de três meses. Houve cinco (0,7%) hospitalizações relacionadas à COVID-19 no grupo de placebo em comparação com zero no grupo de adintrevimabe. Em uma análise exploratória pré-especificada da coorte PrEP, com 402 participantes (196 e 206 nos grupos de adintrevimabe e placebo, respectivamente) após o surgimento do Omicron (BA.1), uma redução clinicamente significativa nos casos de COVID-19 sintomática foi observada com o adintrevimabe, em comparação com o placebo. O adintrevimabe foi associado a uma redução do risco relativo de 59% e 47% com uma duração mediana de acompanhamento de 56 e 77 dias, respetivamente (p nominal <0,05).

Na análise de eficácia primária na coorte de PEP, o adintrevimabe atingiu significância estatística e foi associado a uma menor incidência de COVID-19 sintomático até o dia 28 em comparação com o placebo (3/173, 1,7% vs. 12/175, 6,9%, respectivamente). A diferença de risco padronizada foi de -4,9% (IC 95%: -8,8, -1,0; p=0,0135), demonstrando uma redução de risco relativo de 75% a favor do adintrevimabe durante 28 dias. Houve duas (1,1%) hospitalizações relacionadas à COVID-19 no grupo do placebo em comparação com zero no grupo do adintrevimabe.

Nas coortes de EVASÃO em 1.239 participantes tratados com adintrevimabe com um intervalo médio de acompanhamento de 140 dias para a coorte PrEP e 126 dias para a coorte PEP a partir de 2 de março de 2022, corte de dados, o perfil de segurança foi semelhante ao do placebo. A incidência de eventos adversos (AEs), incluindo eventos adversos graves (SAEs), foi semelhante entre os grupos do adintrevimabe e do placebo. Nenhum SAE relacionado ao medicamento do estudo, incluindo mortes, foi relatado. Os AEs relatados com mais frequência foram reações no local da injeção, a maioria de gravidade leve ou moderada que ocorreram com frequência semelhante em ambos os grupos.

STAMP – Dados Preliminares
STAMP é um ensaio clínico global, multicêntrico, duplo-cego, controlado por placebo de Fase 2/3 que avalia o adintrevimabe na dose de 300 mg IM em pacientes com COVID-19 leve a moderado com alto risco de progressão da doença. O adintrevimabe foi associado a uma incidência estatisticamente significativa menor de hospitalização relacionada à COVID-19 ou morte por todas as causas até o dia 29 em comparação com o placebo (8/169, 4,7% vs. 23/167, 13,8%), com uma diferença de risco padronizada de -8,6% (IC 95%: -14,65, -2,57; p=0,0052), demonstrando uma redução de risco relativo de 66% em favor do adintrevimabe. Houve uma morte (0,6%) no grupo do adintrevimabe, em comparação com seis mortes (3,6%) no grupo do placebo até o dia 29. Em pacientes tratados dentro de três dias do início dos sintomas (adintrevimabe n=91, placebo n=85), o adintrevimabe reduziu o risco de hospitalização pela COVID-19 ou morte por qualquer causa em 77% em comparação com o placebo. O STAMP inscreveu 63 participantes (29 no grupo do adintrevimabe e 34 no grupo do placebo) com infecção pela COVID-19 com a variante Omicron SARS-CoV-2. Houve dois eventos de hospitalização relacionada à COVID-19 e zero morte até o dia 29 entre os pacientes com a variante Omicron, e ambos os eventos de hospitalização ocorreram no grupo do placebo.

No STAMP, em 192 participantes tratados com o adintrevimabe com um acompanhamento médio de 73 dias no grupo do adintrevimabe a partir de 2 de fevereiro de 2022, o corte de dados, a incidência de EAs, incluindo SAEs, foi menor no grupo do adintrevimabe. Nenhum SAE relacionado ao medicamento do estudo, incluindo mortes, foi relatado. Os EAs relatados com mais frequência foram reações no local da injeção, todas de gravidade leve ou moderada que ocorreram com frequência semelhante em ambos os grupos.

“Em nome de toda a equipe da Adagio, gostaria de agradecer aos inúmeros investigadores, equipes clínicas e, mais importante, aos pacientes, familiares e cuidadores pela sua participação nos nossos ensaios clínicos. Estamos encorajados pelos dados e estamos ansiosos para solicitar a aprovação nos EUA e discutir esses resultados com a FDA e outras autoridades reguladoras. Além disso, estamos dando continuidade aos nossos esforços de pesquisa para aprimorar a atividade do adintrevimabe contra o Omicron e identificar anticorpos direcionados a novos domínios, o que fornecerá potenciais candidatos a produtos adicionais para desenvolvimento clínico. Em conjunto, esses esforços mostram a capacidade e a experiência da nossa plataforma para descobrir, elaborar e projetar novos anticorpos, e executar ensaios clínicos globais, para abordar potencialmente doenças infecciosas”, disse Ellie Hershberger, Pharm.D., diretora de desenvolvimento da Adagio.

Atualizações Adicionais de Desenvolvimento e Pesquisa
A Adagio continua a alavancar sua plataforma e experiência, realizando vários esforços para lidar com a COVID-19, outros coronavírus, gripe e outras doenças infecciosas, incluindo:

  • Avanço de um estudo de Fase 1 em voluntários saudáveis para avaliar a farmacocinética e a segurança de doses adicionais mais altas de adintrevimabe para complementar os dados gerados até o momento, que avaliou doses de até 600 mg IM. Dados preliminares de segurança até duas semanas após a dosagem sugerem um perfil de segurança favorável na dose de 1200 mg administrada com injeção IM ou intravenosa (IV).
  • Esforços contínuos para modificar o adintrevimabe para aprimorar a ligação às subvariantes Omicron (BA.1 e BA.2) a fim de aumentar a potência de neutralização, mantendo a ampla neutralização observada in vitro contra outras variantes preocupantes do SARS-CoV-2. As variantes reprojetadas de ADG20 mostram mais de 100 vezes de melhoria na ligação e até 40 vezes de atividade neutralizante aprimorada contra a variante Omicron BA.1, mantendo a atividade contra todas as outras variantes preocupantes testadas até o momento.
  • Esforços contínuos de descoberta para avaliar anticorpos monoclonais adicionais da biblioteca proprietária da empresa de anticorpos SARS-CoV-2 anteriormente isolados para amplitude e potência de neutralização, que podem ser desenvolvidos como um tratamento autônomo ou terapia combinada. Novos anticorpos isolados de doadores de infecção por avanço do Omicron exibiram atividade in vitro contra o vírus SARS 2003 e todas as variantes preocupantes do SARS-CoV-2 testadas até o momento, incluindo as variantes BA.1 e BA.2.
  • Esforços contínuos de descoberta para identificar novos anticorpos amplamente neutralizantes que visam epítopos dentro e fora do domínio de ligação ao receptor de SARS-CoV-2 e anticorpos neutralizantes de pan betacoronavírus.

Demonstração Financeira do Ano e do Quarto Trimestre de 2021

  • Posição de Caixa e Orientação Financeira: Caixa, equivalentes de caixa e títulos negociáveis de US$591,4 milhões em 31 de dezembro de 2021. Com base nos planos operacionais atuais, a Adagio espera que seu caixa existente, equivalentes de caixa e títulos negociáveis permitam que a empresa financie suas despesas operacionais e requisitos de despesas de capital até o segundo semestre de 2024.
  • Despesas de P&D: Despesas de pesquisa e desenvolvimento (P&D), incluindo despesas de pesquisa e desenvolvimento em andamento, de US$68,4 milhões no trimestre findo em 31 de dezembro de 2021 e US$190,4 milhões no ano findo em 31 de dezembro de 2021.
  • Despesas de SG&A: Despesas de vendas, gerais e administrativas (SG&A) de US$14,7 milhões para o trimestre findo em 31 de dezembro de 2021 e US$36,5 milhões para o ano findo em 31 de dezembro de 2021.
  • Prejuízo Líquido: Prejuízo líquido de US$83,0 milhões, ou básico e diluído de US$0,77 por ação, para o trimestre findo em 31 de dezembro de 2021, e US$226,8 milhões, ou básico e diluído de US$5,32 por ação, para o ano findo em 31 de dezembro de 2021.

Sobre o Adintrevimabe
O Adintrevimabe (ADG20), o principal candidato a produto da Adagio, foi projetado para ser um anticorpo potente e amplamente neutralizante para a prevenção e tratamento da COVID-19, e doenças causadas pela maioria das variantes, como um agente único ou combinado. O adintrevimabe está sendo avaliado em dois ensaios clínicos de Fase 2/3 separados: o ensaio EVADE para a prevenção da COVID-19 em ambientes pós-exposição e pré-exposição e o ensaio STAMP para o tratamento da COVID-19. Os dados preliminares destes ensaios demonstraram que, na população pré-Omicron, o adintrevimabe atingiu os objetivos primários em todas as três indicações, demonstrando uma eficácia estatisticamente e clinicamente significativa. Em cada um dos ensaios, a aplicação intramuscular (IM) do adintrevimabe de 300 mg apresentou um perfil de segurança semelhante ao do placebo. O adintrevimabe também está sendo avaliado em um estudo de Fase 1 para avaliar a segurança e a farmacocinética em doses mais altas, e a partir de um corte de dados provisórios, nenhum evento adverso relacionado ao medicamento do estudo, eventos adversos graves, reações no local da injeção ou reações de hipersensibilidade foram relatados em todos os níveis de doses avaliados. O adintrevimabe é um anticorpo monoclonal investigacional que não está aprovado para uso em nenhum país. A segurança e eficácia do adintrevimabe não foram estabelecidas.

Sobre a Adagio Therapeutics
A Adagio (Nasdaq: (ADGI) é uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções com base em anticorpos para doenças infecciosas com potencial pandêmico. A empresa está desenvolvendo seu principal candidato a produto, o adintrevimabe, para a prevenção e tratamento da COVID-19, a doença causada pelo vírus SARS-CoV-2 e suas variantes. Além da COVID-19, a Adagio está utilizando recursos robustos de descoberta e desenvolvimento de anticorpos que permitiram o avanço acelerado do adintrevimabe em ensaios clínicos para desenvolver opções terapêuticas ou preventivas para outras doenças infecciosas, como outros tipos de coronavírus e gripe. O adintrevimabe é um anticorpo monoclonal investigacional que não está aprovado para uso em nenhum país. A segurança e eficácia do adintrevimabe não foram estabelecidas. Para mais informação, visite www.adagiotx.com.

Declarações de Previsão
Este comunicado para a imprensa contém declarações consideradas declarações de previsão de acordo com o Private Securities Litigation Reform Act of 1995. Palavras como “antecipa”, “acredita”, “poderia”, “espera”, “pretende”, “potencial”, “projeta”, e “futura”, e expressões similares são usadas para identificar declarações de previsão. As declarações de previsão incluem declarações sobre, entre outras coisas, a ocasião, progresso e resultados dos nossos estudos pré-clínicos e ensaios clínicos do adintrevimabe, a revisão e análise dos dados de nossos ensaios em andamento e a ocasião dos mesmos, a iniciação, modificação e conclusão dos estudos ou ensaios e trabalhos preparatórios afins, e nossos programas de pesquisa e desenvolvimento; nossos planos relacionados ao envolvimento com autoridades regulatórias, incluindo a ocasião de quaisquer submissões ou pedidos regulatórios; nossa busca de outras estratégias para ampliar nosso portfólio de mAbs de SARS-CoV-2 para abordar outras variantes de SARS-CoV-2 de preocupação, incluindo as variantes Delta e Omicron; nossos esforços de descoberta para identificar novos anticorpos amplamente neutralizantes que visem epítopos distintos, dentro e fora do domínio de ligação ao receptor de SARS-CoV-2 e outros beta coronavírus; nossa cash runaway previsto; e outras declarações que não sejam fatos históricos. Podemos não atingir os planos, intenções ou expectativas mencionadas nas nossas declarações de previsão, e você não deve depositar confiança indevida nas nossas declarações de previsão. Essas declarações de previsão envolvem riscos e incertezas que podem fazer com que nossos resultados reais sejam substancialmente diferentes dos resultados descritos ou implícitos nas declarações de previsão, incluindo, sem limitação, os impactos da pandemia de COVID-19 nos nossos negócios dos nossos colaboradores, nossos ensaios clínicos e nossa posição financeira, dados inesperados de segurança ou eficácia observados durante estudos pré-clínicos ou ensaios clínicos, a previsibilidade do sucesso clínico do adintrevimabe, com base na atividade de neutralização nos estudos pré-clínicos, variação dos resultados nos modelos usados na previsão de atividade contra as variantes preocupantes doSARS-CoV-2, taxas de ativação ou inscrição no local de ensaios clínicos inferiores ao esperado, mudanças na concorrência esperada ou existente, mudanças no ambiente regulatório e as incertezas e o momento do processo de aprovação regulatória, incluindo os resultados das discussões sobre os ensaios clínicos Fase 2/3 com as autoridades regulatórias, e o resultado de qualquer solicitação de aprovação de uso de emergência. Outros fatores que podem fazer com que nossos resultados reais sejam substancialmente diferentes dos resultados descritos ou implícitos nas declarações de previsão neste comunicado para a imprensa, descritos no título no Formulário 10-Q dos “Fatores de Risco” do trimestre encerrado em 30 de setembro de 2021, arquivado na Comissão de Valores Mobiliários (“SEC”) e outros documentos arquivados no SEC e nos relatórios futuros da Adagio a serem arquivados no SEC. Tais riscos podem ser amplificados pelos impactos da pandemia de COVID-19.  As declarações de previsão contidas neste comunicado para a imprensa são válidas a partir desta data, e a Adagio não se compromete a atualizar essas informações, exceto se exigido por lei.

Contatos
Contato com a Mídia:
Dan Budwick, 1AB
dan@1abmedia.com

Contato com o Investidor:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)

December 31,
2021 2020
Assets
Current assets:
Cash and cash equivalents $ 542,224 $ 114,988
Marketable securities 49,194 —
Prepaid expenses and other current assets 25,293 2,394
Total current assets 616,711 117,382
Property and equipment, net 83 —
Other non-current assets 3,297 —
Total assets $ 620,091 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable $ 5,783 $ 8,153
Accrued expenses 56,277 4,919
Total current liabilities 62,060 13,072
Early-exercise liability 6 11
Other non-current liabilities 6 —
Total liabilities 62,072 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C), $0.0001 par value; no shares authorized, issued and outstanding at December 31, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $0 and $169,900 at December 31, 2021 and December 31, 2020, respectively — 169,548
Stockholders’ equity (deficit):
Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at December 31 2021; no shares authorized, issued and outstanding at December 31, 2020 — —
Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 111,251,660 shares issued and 110,782,909 shares outstanding at December 31, 2021; 150,000,000 shares authorized, 28,193,240 shares
issued and 5,593,240 shares outstanding as of December 31, 2020		 11 1
Treasury stock, at cost; 468,751 shares and 22,600,000 shares at December 31, 2021 and December 31, 2020, respectively — (85 )
Additional paid-in capital 850,125 154
Accumulated other comprehensive loss (8 ) —
Accumulated deficit (292,109 ) (65,319 )
Total stockholders’ equity (deficit) 558,019 (65,249 )
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 620,091 $ 117,382

ADAGIO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)

Year Ended
December 31, 2021		 Period from
June 3, 2020
(Inception) to
December 31, 2020
Operating expenses:
Research and development(1) $ 182,891 $ 21,992
Acquired in-process research and development(2) 7,500 40,125
Selling, general and administrative 36,517 3,210
Total operating expenses 226,908 65,327
Loss from operations (226,908 ) (65,327 )
Other income (expense):
Other income (expense), net 118 8
Total other income (expense), net 118 8
Net loss (226,790 ) (65,319 )
Other comprehensive income (loss):
Unrealized loss on available-for-sale securities, net of tax (8 ) —
Comprehensive loss $ (226,798 ) $ (65,319 )
Net loss per share attributable to common stockholders, basic and diluted $ (5.32 ) $ (18.10 )
Weighted-average common shares outstanding, basic and diluted 42,621,265 3,608,491

(1) Inclui valores de partes relacionadas de US$4.150 para o ano findo em 31 de dezembro de 2021 e US$595 para o período de 3 de junho de 2020 (início) a 31 de dezembro de 2020.
(2) Inclui valores de partes relacionadas de US$7.500 o ano findo em 31 de dezembro de 2021 e US$39.915 para o período de 3 de junho de 2020 (início) a 31 de dezembro de 2020.

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Yohannes Kolmodin: His works in the History and Culture of Eritrea

He is a former Journalist and an author who has recently published a historical book on Eritrea. While doing other researches, he found important materials about the Eritrean society from before more than 100 years. Then he decided to do further research and compile a small book with a rich cultural and linguistic texture. ‘Yohannes Kolmodin: His works in the History and Culture of Eritrea’ is a piece that is both informative and resourceful. It says a lot about the Eritrean culture and is a springboard to other studies and researches in the area. Here is our interview with the author of the book, Mr. Tedros Mhretu.

Thank you for your time Mr. Tedros, please introduce yourself to our readers.

My name is Tedros Mhretu. I was born in Ethiopia and came to Eritrea at the age of 11 and stayed until I completed high school at Barka Secondary School in Asmara. Then I left for Sweden and took my first degree in international relations and my Masters in International Relations and Journalism. Then I worked for different media outlets in Sweden such as Dagens Nheter, Swedish radio and Deutche Welle. I had worked in the positions of a reporter and editor. Then I came to Eritrea around 2010-2011 to introduce Yohannes Kolmodin and his book; ‘The Story of Hazega and Tseazega’. It was after 2011 that I discovered he had collected a vast amount of manuscripts from Eritrea. So, then I came to Asmara to introduce him and his works to the people. As part of that, I wrote an article on Haddas Eritra, a National Tigrigna Newspaper. The article mostly introduced Yohannes Kolmodin and his footprints in Eritrea. It was published in June 2012.

After that, I received a lot of feedback from readers most of which suggested for it to be upgraded to a book. Many questions then came to my head, but in the end I decided to do additional research and develop it into a book. Even after I decided to write it, it took me a long time before I actually started to do my research.

What initiated your interest on Yohannes Kolmodin and His works?

The main reason that grasped my interest to study Yohannes and his work is when I came across his book many years ago. Then parallel to my journalism studies, I had interest in different types of historical events in the times of Kolmodin in the Horn of Africa, particularly in Ethiopia. Then I knew he had written a book but didn’t know about the other manuscripts he had on Eritrea.

I found out about the other aspects of his works while going through other research materials in the Horn of Africa. I came across a book in which he was referenced to, that he collected Eritrean literature. That became the beginning of my research on Yohannes Kolmodin and his time in Eritrea. That was eye opening for me and got me curious so I came to Uppsala University and I ordered the materials that were collected during his name. When it arrived, it was surprisingly a big package; it got me stunned. So, I decided to take my time with it, go over it one by one. To look closely at the content and what use could come out of it. And it was handwritten, mostly by Yohannes himself. He was well versed in Tigrigna, Tigre, Blen and Kunama. So, when I discovered this treasure, it was a big surprise and I told myself that I had to do something about it.

Writing a book about him was not something that I set for at first. The first idea I had was introducing t h i s information on Yohannes and his work to the Eritrean people . Then as I mentioned earlier, I came back to Eritrea and wrote a big article on the general introduction of the historical researcher and his works on Eritrean literature; uncovered that he had done more than ‘The Story of Hazega and Tseazega’. Then after I received a lot of feedback from readers, I convinced myself that I had to write a book about him. I was very impressed when I discovered the works he had done and the manuscripts he had collected during his time in Eritrea between 1908 and 1911. It was quite impressive and had me motivated to write a book about it.

Can you give us a short summary of this book?

This book is titled, “Yohannes Kolmodin: His works in the History and Culture of Eritrea”. The first section is composed of four chapters. The first chapter being about the background of Yohannes Kolmodin, the second one deals with Yohannes’ stay in Eritrea from 1908 to 1910. It outlines what he did, his goals in this area and the challenges and encounters that he had. The third chapter mainly discusses his main book, ‘The story of Hazega and Tseazega’, its contents, the aim it was written for and the storytellers in the book. I identified them one by one and found many letters that were exchanged between Yohannes and his assistants, Yohannes and his family in Sweden, in Uppsala University.

In chapter four, you will find the aspects of Yohannes Kolmodin’s works outside of Eritrea. He came to Eritrea when he was 24 years old; inexperienced and came right out of school but he was a very exceptional person. He could speak more than 27 languages, including four from Eritrea. After he came back to Sweden in 1910, he did his research and wrote his PhD dissertation about Hazega and Tseazega. After that, he worked as part of the students’ movement in Sweden. He did a lot of things and got involved in many political issues of his time; issues of the first world war inside and outside of his country. Then he moved to Turkey in 1917 and stayed there until 1930. So, for thirteen years, he was working in Turkey; fluent in Turkish and even made big contributions in the development of the Turkish script from Arabic to Latin. Yohannes was an important part of the transition. So, chapter four is all about the works he has done and manuscripts he has collected outside of Eritrea.

Section two deals with all the materials and manuscripts he had collected during his stay in Eritrea. It is not possible for me to put all the materials he has collected in one book so I have been selective about the manuscripts that I showcased in my book. It is a load of information and requires a research as big, so I had to be selective. Thereafter, I did other researches on the ones that I selected, because some materials were missing and I couldn’t identify some of the personalities mentioned in them. We did an extensive research with Mr. Solomon Tsehaye, an Eritrean author of such fields.

What did you want to achieve by writing this book?

The aim of this book is multifaceted. As you can see, it’s a small book but it is rich in content. First I was trying to introduce him and then the works he has done in Eritrea, those who supported him, the source of his information, the story tellers. I have identified most of the actors and stakeholders in his collections. It is also to introduce this kind of material that have been collected more than a hundred years ago. It is very raw, just a bunch of cultural and linguistic experiences. We have lost touch of some of the words that you find in this manuscripts; they are almost foreign to us now. To study and recall the original version of the languages that were spoken by those people that existed more than 100 years ago is very exciting. The question is how we can adopt, use and include it in our daily linguistics.

That being the primary objective, the second is for the book to serve as a reference and a starting point for deeper and further linguistic and cultural studies. So, for those who are interested or in the field of history, language and archaeology, it is a good material, a foundation to build something out of it. Yohannes himself was not bound to one field of study. Though by profession he was focused on Semitic languages, he had multiple works he was engaged in.

People will be able to know a deeper version of their history and the languages of their forefathers. You can see how rich and beautiful the languages and cultures are just by going through some of the manuscripts. And more than admiring it, we can also adopt it. So, it’s useful for both the professional and non-professional part of the society.

Moreover, another big thing about this book is that it has inculcated information to the readers. It was released in Sweden about 2-3 months ago and it was confirmed to be eye opening for many people because not many people knew that this kind of culture, language and information was collected and well noted. Our stories are normally based on oral traditions; the information is orally passed down from one generation to another.

What makes the information Yohannes collected important is the fact that they were collected in a written form. So, now, I expect the book to have the intended informative effect on the people; about their culture, language, tradition, history; how it was formed and developed, written and spoken. As for the professionals, I expect this piece to come in handy as a motivation and a source for them to develop their studies.

What are your upcoming writing projects?

I am set to becoming a full time writer. So, as I have been working as a journalist and other related fields for a very long time, I am planning to engage in comprehensive studies and write books. I will hopefully release another work very soon. I have thrown in the bait and I expect it to serve as a stepping stone for other researches. There is a lot of information that has been uncovered after I have published this book and that too could be an additional source to the materials on the table. So, now, it’s up to other people’s initiative to take up the work. Of course I will update it someday because I have found new information about his assistant, Bahta Tesfayohannes, which was very instrumental to the completion of the story of Hazega and Tseazega. I didn’t know who this man was and what background he came from. It is now after I published this book that his relatives contacted me and gave me some background information about him. Now I know he was an important part of the picture and had to be included. In addition, I have come across some other information that can come in handy; information about the people who Yohannes Kolmodin has mentioned in his book, their direct descendants and so on. So, I am still collecting all the additional information that is flowing in after I have published my book but I will gather it and use it to update this version of my book.

Thank you very much. If you have any final remarks?

My message is that we have to focus on our history, background and cultures. I understand that we are going through a difficult time and struggle now, as we have always been for a long time, but we always need to maintain our focus. Above all, reading is the most important thing here. So, my message wraps up into “Read, Read, and Read”.

Source: Ministry of Information Eritrea

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Rapeseed cultivation: a promising initiative towards oilseed production

The Ministry of Agriculture (MoA) has assessed the pilot rapeseed cultivation project which was conducted in the previous season on 76 hectares across the Central and Southern regions.

According to Ms. Merry Kahsay, Agronomy expert at the Crop and Livestock Development Division, the MoA began rapeseed multiplication in 2010 through the National Agricultural Research Institute (NARI). Even though rapeseed cultivation in Eritrea goes back to 10 years, its introduction to farmers has been delayed for several reasons, particularly because of post-harvest and oil processing issues.

During the rainy season of 2021, the MoA undertook another initiative to demonstrate rapeseed cultivation in piloted areas of Central and Southern Region, Ms. Merry explained. In line with this initiative, the MoA tested an oil extracting machine in its Kehawta workshop to encourage farmers to produce rapeseed for oil production.

She also outlined that before distributing the seed, which was supplied by NARI, the MoA conducted a series of public awareness raising programs. These covered numerous topics, including rapeseed management, fertilizer and moisture requirement, sowing time, sowing rate and methodology, weeding and thinning, pests and diseases, and harvesting.

Subsequently, 58 hectares of land in six sub-regions of the Southern region (Dubarwa, Medefera, EmniHayli, Dekemhare, Segeneyti and Adi qeyih) and 18 hectares of land in the Central region (sub-regions of Asmara, Galanefhi, and Berik) were piloted, Ms. Merry indicated.

In total, 300 farmers participated in the project, including 32 females. “Learning from the previous challenges and experiences, the Ministry has a plan to expand rapeseed multiplication vigorously in the coming season to make it one of the important oil crops, like sesame and cotton, which are cultivated mostly in the Gash Barka region,” Ms. Merry stated.

Mr. Tekle Teferi is a senior researcher at the Crop Improvement Division of the NARI. According to him, rapeseed crop was primarily introduced in Halhale for trial purposes in 2010. At that time, a number of improved rapeseed varieties were imported and a series of trials were carried out to examine their climatic adaptation and yield potential in different areas. Afterward, two varieties which demonstrated satisfactory performance were selected for multiplication and then distributed to farmers through the Agricultural Extension Department.

Mr. Tekle explained that the yield of rapeseed is greatly influenced by the availability of water and climatic suitability. The yield potential of the two selected rapeseed varieties ranges from 12-14 quintals per hectare under rainfed farming and 18-20 quintals per hectare if supplemented with irrigation. The crop reaches harvest between 90-120 days and does better in clay and clay loam soil with good drainage.

Mr. Tekle underscored that rapeseed is an oil crop that has around 35 percent oil content. Moreover, it has a number of advantages in that it is a good and attractive source of pollen for honey bees and its bagasse and cake are also good fodder for animals. Overall, if rapeseed is properly managed, it can be a rewarding cash crop and has great potential to be one of the most important oil crops in the country.

Experiences of Local Experts and Farmers

Mendefera sub-region

Mr. Mihreteab Negash is a crop production expert in the sub-region of Mendefera. He explained that the sub-region is famous for its multi-crop variety cultivation, which includes field crops, pulses, oil crops, and fruits and vegetables. Livestock production and beekeeping are also commonly practiced. He recalled that rapeseed was cultivated on a trial basis five years ago and went on to note that, “This year, we tried to cultivate it among six exemplary farmers, and the yield was promising.” He concluded that other farmers are also motivated to join the initiative if they can find a market for their harvest.

Mr. Kahsay Haile is one of the most progressive farmers in the region and he has been involved in different agricultural activities since 1999. He described how he has been acquainted with oil plants, like olive trees, for many years.

“When I was asked by the Ministry of Agriculture to cultivate rapeseed in the previous summer, I didn’t hesitate because I have an ambition to focus on oil seeds for commercial purposes. That’s why I cultivated a number of olive trees in the past. Currently, my olive trees have began bearing fruits,” he explained.

Commenting on management practices and harvest, he indicated that the sub-region of Mendefera possesses suitable climatic conditions for rapeseed cultivation. After he had irrigated his farmland, he harvested around 23 quintals per hectare. Looking forward, Mr. Kahsay also stated that he will expand his activities further in the coming rainy season.

Segeneyti sub-region

Mr. Iyassu Asefaw is head of the Agriculture Office in the sub-region of Segeneyti, an area with a large number of farmers involved in the rapeseed cultivation initiative.

Mr. Iyassu explained that there were 113 farmers from 18 villages involved in the iniatitive, working on more than 26 hectares of land.

“We received 210 kilograms of seed and were recommended to plant 8 kilograms of rapeseed per hectare. Since it was our first time and we were aiming to multiply seeds, around 20 hectares were cultivated under irrigation. The rest were cultivated under rainfed conditions” he explained, before adding, “Even though we didn’t meet the ideal yield in our first experience, we will strive to improve performance in the coming year.”.

To encourage farmers, the government purchased the harvested seed at approximately 25 percent higher than the actual market price.

Furthermore, Mr. Iyassu described how the initiative has expanded awareness and brought farmers together to share their experiences. Now, more farmers understand that rapeseed is important for biodiversity improvement. With bees especially drawn to its flowers, many beekeepers are also motivated to cultivate it in the coming season.

Finally, Mr. Iyassu stated that there were some minor challenges in that the crop was repeatedly attacked by weeds, especially during its initial growth stages, while harvesting is laborious and susceptible to bird attack.

Mr. Teame Ghebreslasie is a vegetable farmer residing in Adi- Baekel, Segeneyti sub-zone. He is a successful farmer, particularly when it comes to wheat and potato seeds multiplication.

Mr. Teame explained that before planting rapeseed, training and support was provided by experts from the regional and central MoA offices.

He described his experience, stating, “I cultivated the seed on a half hectare of land and harvested around 2.33 quintals. While the yield could have been better, I am convinced that with experience and proper management it can easily be cultivated in our area. I have learnt a lot with regards to its management practices and will cultivate it in a more organized way in the coming season.”

Mr. Teame also mentioned its importance as a bee forage, and thanked the MoA for the initiative and support.

Another participant in the initiative was Priest Mehari Habtetsion, a farmer living in Degra-Merieto who cultivates vegetables and crops.

He recalled that he was slightly hesitant about the initiative because he lacked experience with cultivating rapeseed. “However, after I received adequate guidance and information from the Ministry, I joined the initiative. I cultivated a half hectare of land and harvested around 3 quintals,” he explained.

He also pointed out that the experience he gained from participating in this pilot project would serve as a stepping stone to his future plans.

Global records indicate that following soya bean and palm oil, rapeseed is the third most important source of vegetable oil in the world. Its oil content ranges from 33-40 percent The oil extractor machine modified by engineers from the MoA has been able to extract about 30 percent oil from previously harvested local seeds.

Source: Ministry of Information Eritrea

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Regular meeting of Northern Red Sea Region Assembly

The Northern Red Sea Region Assembly held its 17th regular meeting on 29 and 30 March under the theme “Sovereign Country for Generations”.

Indicating that heavy sacrifice has been paid and is being paid to handover to generations a sovereign and developed country in which social justice prevails, Mr. Ibrahim Ali Sheik, Chairman of the regional Assembly, called for integrated effort to strengthen development programs aimed at improving the livelihoods of the public.

At the meeting, reports on the implemented development programs of 2021 and charted out programs for 2022 have been presented and members of the Assembly conducted extensive discussion.

The participants also discussed on the efforts that are being exerted and challenges encountered to ensure potable water supply and health of the society, activities to develop students’ school enrolment, as well as to boost agricultural production and water and soil conservation activities.

They also adopted various recommendations including to provide educational opportunity to school aged children, alleviate potable water supply problems in Dahlak, Bada, Naro, Kilamet and Afabet town, as well as to introduce community based environmental sanitation program.

The Assembly also conducted extensive discussion on the charted-out development programs for 2022.

Pointing out that listening and addressing demands of the public is the responsibility of the Assembly, Ms. Asmeret Abraha, Governor of the Northern Red Sea Region, called on the members of Assembly to play a leading role in encouraging the public to reinforce participation in the implementation of the charted-out development drives.

Source: Ministry of Information Eritrea