Atea Pharmaceuticals IncAVIRannounced 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.
