FDA Fast Tracks Bemnifosbuvir for COVID-19

Boston-based Atea Pharmaceuticals announced today the FDA has granted the company Fast Track designation (FTD) for bemnifosbuvir for the treatment of COVID-19 for patients who are at high risk for disease progression regardless of vaccine status. This antiviral is an oral, direct-acting agent is being evaluated in the global phase 3 SUNRISE-3 trial.

“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,” Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals, said in a statement.

Trial Details
The SUNRISE-3 trial is a randomized, double-blind, placebo-controlled, global study evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC).

They are looking to enroll at least 1500 high-risk, participants 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.

The primary endpoint of the study is all-cause hospitalization or death through Day 29 in the supportive care population of at least 1300 patients evaluating bemnifosbuvir as monotherapy.

The patient population being enrolled in the trial included patients ≥ 80 years old, patients ≥ 65 years old with at least one major risk factor, and immunocompromised patients ≥ 18 years old, all regardless of COVID-19 vaccination status.

“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,” Sommadossi said.

The Therapy’s Mechanism of Action
Bemnifosbuvir is a nucleotide polymerase inhibitor, targeting the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is unlikely to change as the virus mutates and variants continue to emerge. This gene is responsible for both replication and transcription of SARS-CoV-2. Bemnifosbuvir targets inhibition of RNA dependent RNA polymerase (RdRp) and nucleotityltransferase (NiRAN), which has the potential to create a high barrier to resistance. 

Sommadossi believes there is a shortage of available therapies and remains a need for clinicans and patients.

“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.”