Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV)

Core Insights - Atea Pharmaceuticals announced that its Phase 2 study for the treatment of hepatitis C virus (HCV) achieved a primary endpoint with a 98% sustained virologic response at 12 weeks post-treatment after an eight-week regimen [1][2] - The regimen, consisting of bemnifosbuvir and ruzasvir, was found to be generally safe and well-tolerated, with no serious adverse events reported [2][3] - Atea plans to initiate a global Phase 3 program in early 2025, following discussions with regulatory bodies [1][3] Efficacy and Safety - The per-protocol treatment adherent patient population achieved a 98% SVR12 rate (208 out of 213 patients) after eight weeks of treatment [2] - The overall efficacy evaluable population, which included 17% non-adherent patients, achieved a 95% SVR12 rate (242 out of 256 patients) [2] - Among treatment adherent patients who were non-cirrhotic and infected with genotypes 1-4, 99% achieved SVR12 [3] Treatment Population and Duration - The Phase 2 study enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis [5] - Treatment adherent patients with cirrhosis achieved an 88% SVR12 rate [3] - For patients with cirrhosis, the treatment duration in the Phase 3 program will be extended to 12 weeks to maximize efficacy [3] Market Context - The HCV market remains underserved, with annual diagnoses in the U.S. outpacing treatment rates [3] - Less than 10% of the HCV patient population in the U.S. is estimated to have cirrhosis, indicating a significant opportunity for effective treatment options [3][9] Drug Profiles - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable pharmacokinetic profile supporting once-daily dosing [7] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies, also supporting once-daily dosing [8] Future Plans - Atea is preparing for the Phase 3 program, which is expected to utilize a fixed-dose combination tablet to enhance patient convenience [4] - Full data from the Phase 2 study are anticipated to be presented at a scientific meeting in the first half of 2025 [2]