Atea Pharmaceuticals(US:AVIR) Globenewswire·2025-06-24 11:00Core Insights - Atea Pharmaceuticals has initiated the global Phase 3 C-FORWARD trial for the combination regimen of bemnifosbuvir and ruzasvir to treat hepatitis C virus (HCV) [1][2] - The regimen is designed to be a potential best-in-class treatment with a short duration of 8 to 12 weeks and low risk for drug-drug interactions [1][3] - HCV remains a significant global health issue, with approximately 50 million people infected worldwide, including 2.4 to 4 million in the US [2][9] Group 1: Trial Details - The C-FORWARD trial is the second Phase 3 trial, complementing the C-BEYOND trial currently enrolling patients in the US and Canada [1][5] - Each Phase 3 trial aims to enroll around 880 treatment-naïve patients, comparing the fixed-dose combination of bemnifosbuvir and ruzasvir to sofosbuvir and velpatasvir [5] - The primary endpoint for both trials is achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks, indicating sustained virologic response (SVR12) [6] Group 2: Efficacy and Safety - Results from a Phase 2 study showed a robust 98% SVR12 rate in the treatment-adherent population and 95% in the efficacy evaluable population [7] - Additional Phase 1 studies indicated a low risk of drug-drug interactions and safety in patients co-infected with HIV [8] - Bemnifosbuvir has demonstrated significantly higher potency compared to sofosbuvir, with a 10-fold increase in activity against various HCV genotypes [11] Group 3: Market Context - The evolving patient population for HCV treatment includes many individuals with co-morbidities and complex medical histories, necessitating more accessible treatment options [3] - The current landscape shows a rising burden of untreated HCV, particularly in Europe, mirroring trends in North America [3] - Atea's regimen is positioned to address these challenges by combining high efficacy, short treatment duration, and minimal drug interaction risks [3]