Atea to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19
Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19
Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression
Trial Expected to Initiate in Fourth Quarter 2022
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Excerpt from the Press Release:
BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced additional details on its clinical development plans for bemnifosbuvir for the treatment of COVID-19. Following meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Emergency Task Force, Atea plans to initiate a global Phase 3 registrational clinical trial of bemnifosbuvir for the treatment of COVID-19 in the fourth quarter of 2022. The trial will evaluate bemnifosbuvir as both monotherapy and combination antiviral therapy in outpatients (non-hospitalized) with COVID-19 who are at the highest risk of disease progression, regardless of vaccination status.
Bemnifosbuvir is an investigational orally administered, non-mutagenic, non-teratogenic, direct-acting antiviral derived from Atea’s purine nucleos(t)ide prodrug platform. Results from the late-stage MORNINGSKY trial showed a 71% reduction in hospitalization (secondary endpoint) with bemnifosbuvir versus placebo (p=0.047, unadjusted, exploratory) (n=207). In a subgroup analysis, patients > 40 years old had an 82% reduction in hospitalization.
“This novel Phase 3 trial design puts us at the forefront of clinical research for new COVID-19 antiviral therapies. In addition to the potential for an approval of bemnifosbuvir as a COVID-19 monotherapy, this trial will move the treatment field forward for combination antiviral therapy, which could be especially meaningful for people at the highest risk of disease progression,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.
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