Clinical TrialJul 28, 2026, 07:02 AM
Atea Pharma's BEM/RZR meets primary endpoint in Phase 3 HCV trial
AI Summary
Atea Pharmaceuticals announced positive topline results from its pivotal C-BEYOND Phase 3 trial for bemnifosbuvir/ruzasvir (BEM/RZR) in treating chronic Hepatitis C virus (HCV). The once-daily fixed-dose combination achieved its primary endpoint of statistical non-inferiority compared to the standard-of-care sofosbuvir/velpatasvir (SOF/VEL), demonstrating high cure rates across patient populations. BEM/RZR showed a 93.9% sustained virologic response (SVR) rate in the mITT population, with a shorter 8-week treatment duration for non-cirrhotic patients. The company anticipates sharing results from its second Phase 3 trial, C-FORWARD, in early 2027.
Key Highlights
- BEM/RZR achieved statistical non-inferiority vs. SOF/VEL in C-BEYOND Phase 3 trial.
- mITT population (n=905) showed BEM/RZR SVR rate of 93.9% vs. 94.8% for SOF/VEL.
- Non-cirrhotic patients (n=721) treated for 8 weeks with BEM/RZR had 93.5% SVR vs. 94.6% for 12-week SOF/VEL.
- Cirrhotic patients (n=184) treated for 12 weeks with BEM/RZR had 95.4% SVR vs. 95.4% for SOF/VEL.
- Safety profile was comparable between treatment arms with no drug-related serious adverse events.
- Results from the C-FORWARD Phase 3 trial (outside North America) are expected in early 2027.
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