Adagio Therapeutics Provides Update on Timing of Adintrevimab EUA Request

WALTHAM, Mass., April 14, 2022 (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, recently announced positive preliminary clinical results from its Phase 2/3 clinical trials of adintrevimab (ADG20) and is providing an update on the anticipated timing for its Emergency Use Authorization (EUA) request for adintrevimab for the prevention and treatment of COVID-19. The Omicron BA.2 variant, which has shown reduced in vitro susceptibility to monoclonal antibodies, has recently emerged as the current predominant variant of SARS-CoV-2 in the U.S. Adintrevimab, which has demonstrated broadly neutralizing activity in vitro against SARS-CoV-2 variants of concern including Alpha, Beta, Delta, Delta Plus, Gamma and Omicron BA.1, has markedly reduced neutralization activity in vitro against the Omicron BA.2 variant. Based on feedback from the U.S. Food and Drug Administration (FDA) regarding adintrevimab’s lack of neutralizing activity against the BA.2 variant, Adagio is pausing the submission of an EUA request. Adagio intends to continue engaging with the FDA and monitor the evolution of SARS-CoV-2 and the in vitro activity of adintrevimab against predominant variants in the U.S. to determine the optimal timing for its planned EUA request.

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