Atea Pharmaceuticals To Advance Global Late-Stage COVID-19 Study of Bemnifosbuvir

  • Atea Pharmaceuticals Inc AVIR announced additional details on its clinical development plans for bemnifosbuvir for COVID-19. 
  • Following meetings with the FDA and the European Medicines Agency Emergency Task Force, Atea plans to initiate a global Phase 3 trial of bemnifosbuvir for 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.
  • The study is designed to enroll at least 1,500 high-risk non-hospitalized patients with mild or moderate COVID-19.
  • In May, Atea reported a topline analysis of data from the MORNINGSKY trial in which the primary endpoint, time to symptom alleviation, was not achieved. 
  • However, a 71% reduction in hospitalization (2.9% versus 10%) was observed in the bemnifosbuvir arm (n=137) versus placebo. In a subgroup analysis, patients > 40 years old had an 82% reduction in hospitalization.
  • New data showed that bemnifosbuvir retained antiviral activity against omicron subvariant lab studies.
  • Price Action: AVIR shares are down 2.51% at $7.78 on the last check Tuesday.
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