The Food and Drug Administration (FDA) has granted Fast Track designation to bemnifosbuvir, a nucleotide polymerase inhibitor, for the treatment of COVID-19.
Bemnifosbuvir in an investigational oral, direct-acting antiviral that targets the SARS-CoV-2 RNA polymerase. According to the developer, Atea Pharmaceuticals, preclinical data have confirmed that the drug is active against all variants that have been tested, including Omicron subvariants BA.4 and BA.5.
The safety and efficacy of bemnifosbuvir is being evaluated in the phase 3 SUNRISE-3 trial (ClinicalTrials.gov Identifier: NCT05629962). The study is expected to enroll at least 1500 high-risk, outpatients with mild or moderate COVID-19, regardless of vaccination status. These high-risk populations include patients over the age of 80, patients 65 years or older with at least 1 major risk factor, and anyone over the age of 18 years who is immunocompromised. Participants will be randomly assigned to receive either bemnifosbuvir 550mg twice daily or placebo in addition to locally available standard of care (SOC) for 5 days.
The primary endpoint of the trial is all-cause hospitalization or death through day 29 in the supportive care population (patients who do not qualify for an authorized oral antiviral treatment or are in a region where oral antivirals are not locally available); in this group, bemnifosbuvir monotherapy will be assessed. Secondary endpoints, including COVID-19 complications, medically attended visits, symptom rebound/relapse and viral load rebound, will be evaluated in both the supportive care population and the combination antiviral population (patients who receive bemnifosbuvir plus SOC that includes other COVID-19 antivirals).
“The decision to grant [Fast Track designation] by the FDA for bemnifosbuvir reflects the continuing unmet medical need that remains for COVID-19 patients,” said Jean-Pierre Sommadossi, PhD, CEO and Founder of Atea Pharmaceuticals. “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.”
Atea Pharmaceuticals announces US FDA Fast Track designation granted to bemnifosbuvir, an investigational oral antiviral, for the treatment of COVID-19. News release. Atea Pharmaceuticals. April 25, 2023. https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-announces-us-fda-fast-track-designation-0.