Adagio Therapeutics has reported that ongoing global Phase II/III clinical trials EVADE and STAMP of its investigational drug adintrevimab (ADG20) for Covid-19 met the primary endpoints.
Based on these results, the company intends to seek an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in the second quarter of this year for adintrevimab to prevent and treat Covid-19. A broadly neutralising antibody, adintrevimab is intended for Covid-19 prevention and treatment.
The multicentre, international, double-blind, placebo-controlled EVADE trial is assessing a 300mg intramuscular (IM) dose of adintrevimab in two separate cohorts for Covid-19 prevention.
Being carried out in adults and adolescents who are at risk of contracting Covid-19, the trial has a pre-exposure prophylaxis (PrEP) cohort and a post-exposure prophylaxis (PEP) cohort.
The initial efficacy assessment data from the PrEP cohort showed that adintrevimab met statistical significance and was linked to reduced occurrence of symptomatic Covid-19 as against placebo, through month three or the emergence of Omicron variant.
A 71% relative decline in risk favouring adintrevimab was also reported.
In the PEP group, the drug offered a statistically significant 75% relative decline in the risk of symptomatic Covid-19 incidence through day 28, as against placebo.
The double-blind, intentional, multicentre, placebo-controlled STAMP trial is studying 300mg IM dose of adintrevimab in mild to moderate Covid-19 patients who are at increased disease progression risk.
Findings showed that adintrevimab was linked to a statistically significant 66% relative decline in the occurrence of Covid-19 associated hospital admission or all-cause mortality through day 29 versus placebo.
In both the trials, a 300mg IM dose of adintrevimab had a safety profile comparable to that of placebo.
Adagio Therapeutics interim CEO and chief operating officer David Hering said: “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.”
In September last year, the company reported that ADG20 showed benefits in its Covid-19 clinical programme.