Atea Pharmaceuticals Announces US-FDA Fast Track Designation Granted to Bemnifosbuvir

Atea Pharmaceuticals 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, a nucleotide polymerase inhibitor, targets 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. Bemnifosbuvir has a unique mechanism of action, with dual targets consisting of inhibition of RNA dependant RNA polymerase (RdRp) and nucleotityltransferase (NiRAN), which has the potential to create a high barrier to resistance. 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 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. 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. The SUNRISE-3, targets 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.

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