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Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV)
Primary Endpoint Achieved with 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) after Short Eight Week Treatment Duration Regimen Was
About this update from Atea Pharmaceuticals, Inc.
[{"type":"text","content":"Primary Endpoint Achieved with 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) after Short Eight Week Treatment Duration Regimen Was Generally Safe and Well-Tolerated Global Phase 3 Program Initiation Expected Early in 2025 BOSTON, Dec. 04, 2024 (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 announced that the Company’s Phase 2 study of the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for treatment of hepatitis C virus (HCV) met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12). Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with a regimen of bemnifosbuvir and ruzasvir. The efficacy evaluable patient population, which included 17% treatment non-adherent patients, achieved a 95% (242/256) SVR12 rate demonstrating the robust potency and forgiveness of the regimen. The regimen was generally safe and well-tolerated with no drug-related serious adverse events or treatment discontinuations. An accompanying slide deck with the topline Phase 2 results is available on Atea’s website here. Full data for the Phase 2 study are anticipated to be presented at a scientific meeting during the first half of 2025. “These high SVR12 results with only eight weeks of treatment with our regimen are extremely exciting and very significant given the unmet needs for today’s HCV patients. We are eager to discuss our program with regulators, including the U.S. Food and Drug Administration, to promptly advance to Phase 3 development early next year,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “The HCV market continues to be underserved, and HCV diagnoses in the U.S. outpace treatment rates annually. Our regimen has a potential best-in-class profile that includes the key features for successfully treating today’s HCV patients including convenience, low risk for drug-drug interactions and short treatment duration. We believe that this regimen has the potential to play a major role in the eradication of HCV in t...