September 30, 2021

Adagio Therapeutics Divulga Novos Dados Destacando o Potencial do ADG20 para Tratamento e Prevenção da COVID-19

ADG20 continua a ser bem tolerado em voluntários saudáveis com meia-vida prolongada e atividade de neutralização do vírus sérico observada até seis meses no Estudo de Fase 1 em Andamento

Dados da Farmacologia de Sistemas Quantitativos/Modelagem Farmacocinética de Corpo Inteiro com Base Fisiológica Confirmam a Avaliação de Dose Intramuscular de 300 mg de ADG20 Administrada por Injeção Intramuscular Única em Estudos de Fase 2/3 em Andamento

Dados a serem apresentados durante a IDWeek 2021 e a 19^th Annual Discovery on Target Conference

WALTHAM, Mass., Sept. 30, 2021 (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 com potencial pandêmico, divulgou hoje novos dados do programa de anticorpos de COVID-19 da empresa. Dados atualizados de seis meses do estudo de Fase 1 em andamento do ADG20 em participantes saudáveis e dados que validam a seleção da dose de 300 mg intramuscular (IM) administrada por injeção única que está sendo avaliada nos ensaios clínicos globais de tratamento (STAMP) e prevenção (EVADE) de Fase 2/3 em andamento da empresa serão apresentados durante quatro sessões de pôster na IDWeek 2021 da Infectious Disease Society of America, a ser realizada de 29 de setembro a 3 de outubro de 2021. Além disso, a diretora científica da Adagio, Laura Walker, Ph.D., apresentará um subconjunto dos dados da Fase 1 do ADG20, bem como informações sobre a identificação e otimização desse candidato clínico a anticorpos diferenciados em uma apresentação oral na 19^th Annual Discovery on Target Conference no dia 30 de setembro de 2021.

“A potência contínua dos dados de segurança e farmacocinética do nosso estudo de Fase 1 é encorajadora e ressalta ainda mais o impacto potencial que um anticorpo como o ADG20 – que foi projetado para ser potente, amplamente neutralizante e administrado por uma única injeção IM – pode ter nas pessoas com ou em risco de COVID-19”, disse Lynn Connolly, M.D., Ph.D., diretora médica da Adagio. “Esses dados da Fase 1, juntamente com a nossa estratégia de seleção de dose, que tomou por base a nossa abordagem de modelagem inovadora, nos permitiram dar início e avançar nossos ensaios principais do ADG20 no tratamento e prevenção da COVID-19. Esses dados serão utilizados no pedido de Emergency Use Authorization (Autorização de Uso de Emergência – EUA) no primeiro trimestre de 2022, podendo viabilizar a oferta de uma opção de tratamento importante para os pacientes.”

Fase 1 Atualização do Estudo
A Adagio está avaliando o ADG20 em um estudo de Fase 1 randomizado, duplo-cego, controlado por placebo de dose única ascendente para avaliar a segurança e tolerabilidade, farmacocinética (PK), imunogenicidade e atividade neutralizante do vírus do soro do ADG20 ex vivo contra o SARS-CoV-2. Os dados de um período de avaliação de seis meses confirmaram a meia-vida prolongada do ADG20, que se aproximou de 100 dias com base nos dados da dose de 300 mg IM que foi administrada como uma única injeção. Além disso, 50% dos títulos de neutralização do vírus sérico aos seis meses após uma dose IM de 300 mg de ADG20 foram semelhantes aos títulos de pico observados com a vacina mRNA-1273 e excederam os obtidos com a série de vacinas AZD1222. É importante ressaltar que o ADG20 foi bem tolerado e sem eventos adversos (AEs) relacionados ao medicamento do estudo, AEs graves ou reações no local da injeção ou de hipersensibilidade relatadas através de um acompanhamento mínimo de três meses em todas as coortes. Os participantes continuarão a ser acompanhados durante 12 meses para a avaliação da segurança e tolerabilidade, PK, imunogenicidade e atividade neutralizante do vírus sérico.

Informações do Pôster da Fase 1: (633) Resultados Preliminares de um Estudo de Fase 1 de Dose Ascendente Única que Avalia a Segurança, os Títulos de Anticorpos Neutralizantes Virais no Soro (sVNA) e o Perfil Farmacocinético (PK) de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença de Coronavírus (COVID-19)

Estratégia de Seleção de Dose
Para confirmar a seleção de dose para os ensaios clínicos globais STAMP e EVADE de Fase 2/3 da Adagio, a empresa modificou um modelo farmacocinético de base fisiológica de corpo inteiro (QSP/PBPK) de sistemas quantitativos existentes para caracterizar melhor a PK de anticorpos monoclonais de meia-vida prolongada no soro e locais principais de replicação viral no trato respiratório. O modelo da Adagio previu adequadamente a priori a PK sérica do ADG20 observada em primatas não humanos (NHPs) e humanos. O modelo foi otimizado com base nos dados do ensaio clínico de Fase 1 da Adagio e depois aplicado para seleção da dose para STAMP e EVADE.

Para o ensaio de tratamento do STAMP, os dados compilados até o momento sugerem que o regime de 300 mg IM tem uma capacidade projetada DE atingir e manter rapidamente as concentrações alvo nos locais principais de replicação viral do tecido, incluindo a capacidade de atingir ocupação quase completa (> 90%) e durável (> 28 dias) do receptor SARS-CoV-2 em uma gama de cargas virais de linha de base. Além disso, para o estudo de prevenção EVADE, os dados compilados até o momento sugerem que o regime de 300 mg IM tem uma capacidade projetada de exceder rapidamente as concentrações séricas alvo na maioria dos pacientes simulados e de manter concentrações potencialmente eficazes por até 12 meses.

Informações do Pôster de Seleção de Dose

(1086) Um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) que Prevê a Farmacocinética Intramuscular (IM) a priori de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
(1089) Uso de um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) para Apoiar a Seleção de Dose de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
(1088) Um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) para apoiar a seleção de dose de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)

Os ensaios clínicos STAMP e EVADE estão abertos para inscrições de pacientes em todo o mundo. Para mais informação, visite clincialtrials.gov.

Sobre o ADG20
O ADG20, um anticorpo monoclonal direcionado à proteína Spike do SARS-CoV-2 e coronavírus relacionados, está sendo desenvolvido para a prevenção e tratamento da COVID-19, a doença causada pelo SARS-CoV-2. ADG20 foi projetado e criado para alta potência e ampla neutralização contra SARS-CoV-2 e sarbecovírus de clado 1 adicionais, direcionando-se a um epítopo altamente conservado no domínio de ligação ao receptor. O ADG20 exibe atividade neutralizante potente contra a cepa SARS-CoV-2 original, bem como todas as variantes preocupantes conhecidas. O ADG20 tem o potencial de impactar a replicação viral e a doença subsequente através de múltiplos mecanismos de ação, incluindo o bloqueio direto da entrada viral na célula hospedeira (neutralização) e a eliminação de células hospedeiras infectadas através da atividade efetora imune inata mediada por Fc. O ADG20 é administrado por meio de uma injeção intramuscular e foi projetado para ter uma meia-vida longa, com o objetivo de fornecer proteção rápida e durável. A Adagio está avançando o ADG20 por meio de vários ensaios clínicos em uma base global.

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. O portfólio de anticorpos da empresa foi otimizado com os recursos de engenharia de anticorpos líderes da indústria da Adimab, e foi criado para fornecer aos pacientes e médicos uma combinação de potência, amplitude, proteção durável (via extensão de meia-vida), capacidade de fabricação e acessibilidade. O portfólio de anticorpos contra SARS-CoV-2 da Adagio inclui múltiplos anticorpos amplamente neutralizantes não competitivos com epítopos de ligação distintos, liderados por ADG20. A Adagio adquiriu a capacidade de fabricação para a produção do ADG20 com fabricantes terceirizados para apoiar a conclusão de ensaios clínicos e lançamento comercial inicial. 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”, “espera”, “pretende”, “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 ADG20, incluindo a ocasião dos nossos pedidos planejados de EUA, início e conclusão de estudos ou ensaios, e trabalhos preparatórios relacionados, o período durante o qual os resultados dos ensaios ficarão disponíveis, e nossos programas de pesquisa e desenvolvimento; nossa capacidade de obter e manter aprovações regulatórias para nossos candidatos a produtos; nossa capacidade de identificar pacientes com as doenças tratadas por nossos candidatos a produtos, e de inscrever esses pacientes nos nossos ensaios clínicos; nossas capacidades e estratégia de fabricação; e nossa capacidade de comercialização com sucesso dos nossos candidatos a produtos. 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 riscos descritos no título “Fatores de Risco” no prospecto da Adagio arquivado na Comissão de Valores Mobiliários (“SEC”) em 6 de agosto de 2021 e nos relatórios futuros da Adagio a serem arquivados na SEC, incluindo o Relatório Trimestral da Adagio no Formulário 10-Q do trimestre encerrado em 30 de junho de 2021. 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

September 30, 2021

WHO: Most of Africa Has Missed 10 Percent COVID-19 Vaccination Goal

Fifteen African countries have succeeded in fully vaccinating at least 10 percent of their populations against COVID-19 by September 30, a goal set by the World Health Organization in May. However, that leaves two-thirds of the continent’s 54 nations extremely vulnerable to the deadly disease.

Several countries have performed extremely well. Seychelles and Mauritius have fully vaccinated more than 60 percent of their populations and Morocco has inoculated 48 percent against the coronavirus.

Richard Mihigo is coordinator of the Vaccine-preventable Diseases Department in the WHO’s regional office for Africa. He said those countries were able to achieve and even excede the 10 percent target because they had a steady vaccine supply available.

He said most had the money to strike bilateral deals to procure vaccine in addition to the supplies delivered through the COVAX facility.

“Unfortunately, 70 percent of African countries have missed this important milestone to protect their most vulnerable, with half of the 52 countries with COVID-19 vaccination programs in Africa having inoculated less than two percent of their populations,” said Mihigo.

That compares to an inoculation rate of 50 percent or higher in wealthier countries.

The WHO reports monthly vaccine deliveries to Africa have increased 10-fold since June. However, it notes more than double that amount is needed to reach the 40 percent immunization target of Africa’s 1.3 billion people by the end of the year.

Mihigo said COVAX is identifying countries that do not have the means to procure vaccines and put them in the front of the line to get enough doses to cover their most at-risk populations. However, he said pledges of doses by wealthier countries need to materialize soon.

“Starting next week, we are sending multi-disciplinary teams of international experts to countries that are struggling to scale up their operations so that we can drill down and identify the bottlenecks so that the local authorities and their partners can remedy them as they continue to rollout the vaccines,” said Mihigo.

On a more positive note, the World Health Organization says COVID-19 infections in Africa dropped by 35 percent to just over 74,000 last week, with more than 1,700 deaths reported in 34 countries.

Despite the declining numbers, the WHO warns people must remain vigilant and continue to adhere to proven public health measures to save lives. Those include the wearing of masks, regular hand washing, and physical distancing.

Source: Voice of America

September 30, 2021

Former Malawi Lawmaker Commits Suicide at Parliament

A former high-ranking lawmaker in Malawi committed suicide Thursday afternoon in the country’s parliament building.

Clement Chiwaya, 50, a former second deputy speaker, fatally shot himself in the head with a pistol while inside the National Assembly. Details about what led Chiwaya to kill himself remained sketchy.

The parliament said in a statement that the public would be informed at an appropriate time, as the Malawi Police Service was investigating the incident.

When in office, Chiwaya represented the opposition United Democratic Front.

According to the statement from parliament, Chiwaya recently was involved in a court case regarding his vehicle. The car was in an accident before the transfer of ownership was completed, and the insurance had expired.

Chiwaya sought help from the government’s Office of the Ombudsman, who made a determination in his favor, but Malawi’s High Court set the determination aside.

The parliament statement said guards have the proper equipment and protocols to ensure safety in the building. However, Chiwaya’s suicide raised concerns.

Former military officer Sheriff Kaisi, a security expert based in Blantyre, said, “To me, I would say that there is negligence on how security should be provided at high-risk places like parliament. This is a wake-up call in the management of security. There is no way you can manage security in that sense, when you have cameras and detectors.”

Chiwaya had used a wheelchair for a number of years. In its statement, the National Assembly said that while Chiwaya’s entrance had set off alerts when he passed through metal detectors Thursday, the alerts were deemed to be from the wheelchair, and therefore guards did not look for any firearms.

Source: Voice of America

September 30, 2021

Delayed Elections Are Underway in Ethiopia

Delayed elections are underway Thursday in four regions of Ethiopia.

Voters in three regions will decide who wins dozens of parliamentary seats in the last round of voting before Prime Minister Abiy Ahmed forms a new government on Oct. 4.

Voters in the fourth region will decide whether to establish their own regional state.

The parliamentary elections are being held in the Somali region, the eastern city of Harar, and in the southwestern Southern Nations, Nationalities, and Peoples’ Region (SNNPR).

Voters in SNNPR are also deciding whether or not to form a regional state.

The elections were delayed by a variety of voter registration irregularities, legal disputes, and security issues.

Abiy is facing mounting global pressure over the war in the northern region of Tigray. Conflict erupted in November 2020 between federal and allied regional forces and forces backed by the Tigrayan People’s Liberation Front.

Ethiopia’s parliament consists of 547 seats, 47 of which are being contested. Abiy’s party previously won 410 of the 436 parliamentary seats that were contested in the June election. It is uncertain when elections for the remaining seats, some of which are in Tigray, will take place.

The TPLF regained control of Tigray in June after months of fighting. The United Nations has said parts of Tigray are experiencing famine because of the war.

Source: Voice of America

September 30, 2021

Weak Borders, Transitional Government Make Sudan Terrorist Target, Analysts Say

The fragile nature of the security situation in Sudan was exposed by a deadly gunfight in Gabra earlier this week. Authorities arrested 11 alleged terrorists following the battle in which five Sudan General Intelligence Service members were killed.

Analysts blamed the violence on the presence of foreign insurgents in the country and the transitional nature of the military-civilian government that has governed Sudan since 2019, when President Omar al-Bashir was ousted by the military after months of protests.

Khalifa Sidiq, a professor at the International University of Africa in Khartoum and an expert on Islamist groups, told VOA that Sudan’s proximity to other troubled states contributes to the problem.

“The Gabra incident,” Sidiq said, “is not removed from that context. During this transitional period, Sudan is experiencing a security crisis with open borders to hot spots in the region.” As examples, Sidiq pointed to Libya and to Somalia, where the jihadi group al-Shabab operates.

“Sudan’s borders with Chad and the Central African Republic are also porous,” he said.

Sudan’s history of terrorism goes back to the 1970s and was amplified during the 1990s, when it harbored al-Qaida leader Osama bin Laden and was found to have assisted al-Qaida in the 1998 bombings of U.S. embassies in Kenya and Tanzania. Only after the ouster of al-Bashir and the payment of $335 million in compensation to the victims of several terror attacks did Washington remove Sudan from its list of state sponsors of terror.

Sidiq pointed out several factors prompting extremist groups to operate in Sudan.

“Among them is the presence of United Nations [and] African Union troops under UNAMID and its successor UNITAMS,” which he said were “foreign multinational forces operating in a Muslim country” that encourage “extremist groups to rise and combat them.”

Cameron Hudson, a senior fellow at the Atlantic Council’s Africa Center who was formerly with the U.S. Special Envoy to Sudan as well as the former White House Africa director, agreed with Sidiq.

“There are genuine security threats in the country and those security threats require a competent, capable and professional security service to confront them. That much is not in doubt,” he said, adding, “I think the challenge that Sudan faces today is beyond these legitimate threats.”

Role of armed forces

This week’s killings in Gabra and an attempted coup last week, Hudson said, should not be used as an excuse by Sudan’s military to undermine the civilian-led government of Prime Minister Abdalla Hamdok.

“This will likely be used by the military to demonstrate that they need to have a prominent role in running the country again,” he said. And this week’s shootings “just further underscore the need for a comprehensive conversation on security sector reform and the role of the military in the country going forward.”

As military and civilian officials in Sudan’s transitional government have traded accusations about what led to last week’s coup attempt, observers said the situation exposed the fragile military-civilian partnership in Sudan’s government.

No clear link to IS

Last year, Hamdok survived an assassination attempt when his motorcade was targeted with explosives while he was on his way to his office. Hudson said it wasn’t clear whether the most recent events were connected to the assassination attempt.

Officials have not released information about the nationalities and motives of the terrorists connected to the latest events in Sudan.

“My sense is that [the Gabra incident] is separate, that there are former regime elements, [including] Islamists, which remain present in the country. I do not think that they are the same as Islamic State cells,” Hudson said. “I think that there’s been no demonstration that there’s overlap between elements of the former regime and more hard-core terrorists — you know, international terrorist elements. That link has not been established.”

Source: Voice of America

September 30, 2021

UN Chief ‘Shocked’ as Ethiopia Expels 7 Aid Officials

The U.N. secretary-general expressed “shock” Thursday after the Ethiopian government announced the expulsion of seven senior U.N. humanitarian officials working in the country.

“In Ethiopia, the U.N. is delivering lifesaving aid — including food, medicine, water, and sanitation supplies — to people in desperate need,” Antonio Guterres said in a statement. “I have full confidence in the U.N. staff who are in Ethiopia doing this work.”

He said the organization is engaging with the Ethiopian authorities “in the expectation that the concerned U.N. staff will be allowed to continue their important work.”

The seven officials have been given 72 hours to leave Ethiopia. They include the U.N.’s deputy humanitarian chief, the deputy humanitarian coordinator, and the U.N. Children’s Agency (UNICEF) representative.

In a tweet, the ministry of foreign affairs said the seven were “meddling in the internal affairs of the country.”

Conflict-induced hunger

The Ethiopian federal government has been engaged in an armed conflict with rebels in the northern Tigray region for nearly one year. The government declared a unilateral cease-fire and withdrew its forces in June, but the conflict has continued to spill into the neighboring regions of Amhara and Afar.

Of the 6 million people who live in Tigray, the U.N. says 5.2 million need some level of food assistance. Over 400,000 people are already living in famine-like conditions, and another 1.8 million people are on the brink of famine.

On Wednesday, U.N. Humanitarian Chief Martin Griffiths said that after 11 months of conflict and three months of a de facto government blockade, the humanitarian crisis in Tigray is spiraling out of control.

In an interview with The Associated Press, Griffiths said the humanitarian crisis in Ethiopia is a “stain on our conscience,” as civilians starve because aid workers are being blocked from getting enough supplies to them.

One hundred aid trucks are needed daily in the region, but in the past week, only 79 in total were allowed in, a U.N. spokesman said.

“Trucks carrying fuel and medical supplies still cannot enter into Tigray,” U.N. spokesman Stephane Dujarric said Wednesday. “Trucks are waiting in Semera, in Afar, to travel to Mekelle.”

The federal government headed by Nobel Peace Prize laureate, Prime Minister Abiy Ahmed, blames the rebels for blocking the aid deliveries.

White House condemnation

“The U.S. government condemns in the strongest possible terms the government of Ethiopia’s unprecedented action to expel the leadership of all of the United Nations organizations involved in ongoing humanitarian operations,” White House spokesperson Jen Psaki told reporters on Thursday.

Earlier this month, U.S. President Joe Biden signed an executive order allowing the government to impose financial sanctions on those who prolong the conflict.

“We will not hesitate to use this or any other tool at our disposal to respond quickly and decisively to those who obstruct humanitarian assistance to people of Ethiopia,” Psaki said.

Source: Voice of America

September 30, 2021

South Africa’s Coal Energy Sector Under Mounting Pressure

Coal provides more than 75% of South Africa’s energy supply, but in the wake of global warming, pressure is mounting for that to change. Protests were seen across the country last week and now a proposed Chinese-backed coal power plant may be scrapped.

It’s what keeps the lights on and industries running.

But South Africa’s coal energy sector is facing mounting pressure at home and abroad to end its use of coal for good.

Frustrated with regular blackouts and the effects of pollution, citizens of the mineral-rich country rallied last week, demanding cleaner, more reliable and affordable alternatives.

Urika Pais was among the protesters from Soweto.

“Electricity has always been a problem in our community. So, community members went forward and they fought for electricity. But when the electricity came, it came at a very high price. We know that solar power is a better solution and it will be cheaper,” said Pais.

South Africa is among the world’s top 15 largest emitters of carbon dioxide. Its reliance on coal stems from having vast quantities of the resource underground.

This week, though, South Africa’s government told the United Nations it is setting more ambitious climate targets.

While environmentalists welcomed the commitment, they say change to the energy sector is not happening fast enough.

Nicole Loser is an attorney with the Centre for Environmental Rights.

“We have to drastically reduce our emissions and reduce our reliance on coal by about 80% within the next 10 years, less than 10 years. We aren’t seeing those changes happening fast enough. We also know that we need to essentially double our renewable energy build our plants — that also is not happening,” said Loser.

As the rest of the world races to tackle climate change, analysts say pressure from business and foreign governments can force a faster green transition in South Africa.

Chris Yelland is an energy analyst with EE Business Intelligence.

“If we do not reduce our dependence on coal, we will be punished by our trading partners who will set up cross-border tariff. And ultimately, South Africa relies on trade with the rest of the world,” he said.

China announced last week that it would no longer fund foreign coal projects. That means a Chinese-backed coal project slated to power a new industrial complex in South Africa’s northern province of Limpopo may not materialize.

Analysts like Chris Yelland say China’s decision will have long-term ramifications.

“China was seen to be perhaps the last outpost of finance that could be available for new coal. And there is nobody else to pick up this ball to finance this new coal-fired power. So, I think the days of new coal in South Africa are over,” he said.

The prospect of canceling coal is a major victory for protesters who want to see South Africa embrace renewables on a larger scale.

Source: Voice of America