The US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to Atea Pharmaceuticals Inc’s 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 of COVID-19 in outpatients at high risk for disease progression regardless of vaccination status. This includes patients over age 80, patients 65 years or older with at least one major risk factor, and anyone over age 18 who is immunocompromised.
“The decision to grant FTD by the FDA for bemnifosbuvir reflects the continuing unmet medical need that remains for COVID-19 patients. FTD has the potential to expedite the development of bemnifosbuvir, and we look forward to ongoing discussions with the FDA,” says Jean-Pierre Sommadossi, PhD, CEO and Founder of Atea Pharmaceuticals, in a release. “Due to the limitations of current antiviral treatments, including drug-drug interactions and potential risks for genotoxicity and reproductive toxicity, as well as the ability of the virus to evade vaccines and monoclonal antibodies, new treatment options are urgently needed. In SUNRISE-3, we are targeting the most vulnerable patient populations who are at the greatest risk for disease progression to severe COVID-19 or mortality and for whom there are currently the fewest treatment options.”
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.
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. 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 US, 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.
The primary endpoint of SUNRISE-3 is all-cause hospitalization or death through day 29 in the supportive care population of at least 1,300 patients evaluating bemnifosbuvir as monotherapy. Secondary endpoints in both the supportive care and combination antiviral populations include: COVID-19 complications, medically attended visits, symptom rebound/relapse, and viral load rebound.