Adagio Therapeutics, Inc. (NASDAQ: ADGI) reports primary endpoints were met with statistical significance for all three indications of the company’s ongoing Phase 2/3 clinical trials evaluating its drug adintrevimab as a pre-and-post exposure prophylaxis and treatment for COVID-19. “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.”
“On behalf of the entire Adagio team, I’d like to thank the numerous investigators, clinical teams and, most importantly, the patients, families and caregivers for their participation in our clinical trials. We are encouraged by the data and look forward to submitting an EUA and discussing these results with the FDA and other regulatory authorities. Further, we are continuing our research efforts to improve adintrevimab activity against Omicron and identify antibodies targeting novel domains, which will provide potential additional product candidates to take into clinical development. Collectively, these efforts showcase the ability of our platform and expertise to discover, design and engineer novel antibodies, and execute global clinical trials, to potentially address infectious diseases,” said Ellie Hershberger, Pharm.D., chief development officer of Adagio.