Atea Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to bemnifosbuvir for the treatment of COVID-19. Bemnifosbuvir is an oral, direct-acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment ofCOVID-19 in outpatients at high risk for disease progression regardless of vaccination status. This includes patients over the age of 80, patients 65 years or older with at least one major risk factor, and anyone over the age of 18 who is immunocompromised.

The FDA's Fast Track program is designed to facilitate the expedited development and review of new drugs or biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Among other things, as a result of the Fast Track designation, Atea may benefit from more frequent communications with the FDA to discuss the development plan of bemnifosbuvir For the treatment of COVID- 19 and rolling review of any completed sections of any resulting New Drug Application (NDA). About the Phase 3 SUNRISE- 3 Trial SUNRISE-3 is a randomized, double-blind, placebo-controlled, global Phase 3 trial designed to evaluate bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC).

It is expected that the study will enroll at least 1,500 high-risk, outpatients with mild or moderate COVID-19, with a global footprint of approximately 300 clinical trial sites planned in the United States, Europe, Japan and rest of the world. Patients will be randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily (BID) plus locally available SOC or placebo BID plus locally available SOC for five days. This trial is comprised of two populations derived from the type of SOC received.