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Full Results from Phase 2 Study Confirmed 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) After Short 8-Week Treatment Duration for Regimen
Results from Phase 1 Study Showed Low Risk for Drug-Drug Interactions with Regimen When Co-Administered with Standard HIV Treatment Regimen
Bemnifosbuvir Was Generally Safe and Well Tolerated with No Dose Adjustment Needed
in Phase 1 Studies in Participants with Hepatic or Renal Impairment
Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, 2025
BOSTON, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today presented results from the full cohort of patients (n=275) enrolled in its Phase 2 study evaluating the once-daily combination of bemnifosbuvir (BEM), an oral nucleotide NS5B polymerase inhibitor, and ruzasvir (RZR), an oral NS5A inhibitor, for the treatment of hepatitis C virus (HCV). The Phase 2 study met its primary endpoints of efficacy and safety. With a short 8-week treatment duration, the Phase 2 results showed a robust 98% (210/215) sustained virologic response rate at 12 weeks post-treatment (SVR12) with the regimen in the "Per-Protocol Treatment-Adherent Population." The SVR12 rate was 95% (245/259) in the "Per-Protocol Regardless of Adherence Population" (also referred to as the "efficacy evaluable population"), which included patients who were not treatment adherent (17%).
Results from three additional Phase 1 studies demonstrated that the combination of BEM/RZR had a low risk of drug-drug interactions (DDIs) and supported the safety of the regimen of BEM/RZR in patients co-infected with HCV and human immunodeficiency virus (HIV) taking a standard HIV treatment, and the safety of BEM in participants with hepatic or renal impairment with no need for dose adjustments.
These results were presented at the European Association for the Study of the Liver (EASL) Congress 2025 from May 7-10 in Amsterdam, Netherlands.
Posted In: AVIR
