Risk of symptomatic COVID-19 was reduced by 71% compared to placebo in pre-exposure prophylaxis and 75% compared to placebo in post-exposure prophylaxis
Risk of hospitalization or death in participants with mild to moderate COVID-19 was reduced by 66% compared to placebo in the primary efficacy analysis population and by 77% compared to placebo in participants who received treatment within three days of symptom onset
Full year and fourth quarter 2021 financial results reported; $591 million in cash and investments expected to be sufficient to fund operations into second half of 2024
WALTHAM, Mass., March 31 (Bernama-GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc. (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases, reported that the primary endpoints were met with statistical significance for all three indications in the company’s ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab (ADG20) as a pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19. EVADE and STAMP were primarily conducted during a time when pre-Omicron SARS-CoV-2 variants were dominant. Following the emergence of the Omicron variant, in a pre-specified exploratory analysis in a subset of the pre-exposure cohort, a clinically meaningful reduction in cases of symptomatic COVID-19 was observed with adintrevimab compared to placebo. Across both trials, a single intramuscular (IM) administration of adintrevimab at the 300mg dose had a similar safety profile to that of placebo. Based on these data, Adagio plans to engage with the U.S. Food and Drug Administration (FDA) and to submit an Emergency Use Authorization (EUA) application in the second quarter of 2022 for adintrevimab for both the prevention and treatment of COVID-19.
In addition, Adagio provided an update on its ongoing Phase 1 study evaluating adintrevimab at higher doses and on research activities related to adintrevimab re-engineering and the identification of new antibodies to potentially address COVID-19 and other viruses.
“COVID-19 continues to pose significant challenges globally as waning immunity combined with the emergence of resistant variants has led to ongoing waves of disease. We believe that a suite of options – spanning prophylaxis and treatment – is needed to effectively address this virus as it continues to evolve, and these data give us confidence in the potential role adintrevimab can play in physicians’ arsenals,” said David Hering, MBA, interim chief executive officer and chief operating officer of Adagio. “Based on the data from both EVADE and STAMP, including the impacts observed in preliminary analyses from participants enrolled after the emergence of the Omicron variant, our team is initiating discussions with the FDA and preparing an EUA submission for adintrevimab. With more than one million doses of adintrevimab secured for 2022 and a solid financial position expected to take us into the second half of 2024, we are optimistic about the road ahead and the impact adintrevimab could have for the many people around the globe, particularly those at high risk with co-morbidities, who continue to need options.”
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