KUALA LUMPUR, March 31 (Bernama) -- Adagio Therapeutics Inc, a clinical-stage biopharmaceutical company, 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.
According to a statement, 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.
“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,” said David Hering, MBA, interim chief executive officer and chief operating officer of Adagio.
“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 the same statement, the company also reported Full Year and Fourth Quarter 2021 Financial Results. Cash, cash equivalents and marketable securities were US$591.4 million as of Dec 31, 2021. (US$1 = RM4.201)
Based on current operating plans, Adagio expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses and capital expenditure requirements into the second half of 2024.
Research and development (R&D) expenses, including in-process research and development expenses, were US$68.4 million for the quarter ended Dec 31, 2021, and US$190.4 million for the year ended Dec 31, 2021.
In addition, selling, general and administrative (SG&A) expenses were US$14.7 million for the quarter ended Dec 31, 2021, and US$36.5 million for the year ended Dec 31, 2021.
More details at www.adagiotx.com.
-- BERNAMA
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