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 onsetFull 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.
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