Atea Pharmaceuticals Inc. (AVIR) has completed patient enrolment in its pivotal North American Phase 3 trial, dubbed C-BEYOND, evaluating the fixed-dose combination of Bemnifosbuvir and Ruzasvir for the treatment of hepatitis C virus.
Hepatitis C remains a major global health challenge, with millions of patients still requiring effective, accessible therapies despite the availability of direct-acting antivirals.
The C-BEYOND study represents one of the first global head-to-head Phase 3 trials of oral antiviral regimens, enrolling more than 880 treatment- naïve adults across approximately 120 clinical sites in the United States and Canada.
The trial is designed to compare Atea's investigational regimen of Bemnifosbuvir and Ruzasvir against a fixed-dose combination of Sofosbuvir, a widely used standard of care.
The primary endpoint will assess sustained virologic response (SVR12), a measure of viral clearance 12 weeks after completion of the therapy, with secondary endpoints evaluating safety, tolerability and resistance profiles.
Bemnifosbuvir, a novel nucleotide polymerase inhibitor, and Ruzasvir, an NS5A inhibitor, are being developed as an oral, once-daily combination therapy. Together, they aim to provide a potent, pan-genotypic regimen with a high barrier to resistance and improved convenience compared to existing therapies.
Completion of enrolment in C-BEYOND marks a significant milestone in Atea's late-stage development program. Topline results from this North American trial are expected in mid-2026, while enrolment in the companion C-FORWARD Phase 3 trial, conducted outside North America, is anticipated to conclude by mid-2026, with results expected by year-end.
Atea highlighted that these trials are the first to directly compare investigational direct-acting antivirals against established regimens, potentially reshaping the competitive landscape in HCV treatment.
The company ended the third quarter of 2025 with cash, cash equivalents and marketable securities of $329.3 million, supporting its ongoing clinical programs.
AVIR has traded in a range of $2.45 and $4.02 over the past year. The stock closed yesterday's trading at $3.17, up 0.96% and rose further in the after-hours trading to $3.25, up 2.52%.
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