Atea Pharmaceuticals Completes Enrollment in Phase 3 C-FORWARD HCV Trial Across 17 Countries

With topline data from two concurrent Phase 3 trials now converging on a single six-month window, Atea Pharmaceuticals is positioning its fixed-dose combination bemnifosbuvir/ruzasvir (BEM/RZR) regimen for a multi-region regulatory filing sequence that will test supply chain and CMO readiness well before any NDA or MAA submission. Enrollment in the C-FORWARD trial closed with more than 880 treatment-naïve patients across approximately 120 clinical sites in 17 countries outside North America.

C-FORWARD is a randomized, open-label study comparing once-daily BEM/RZR against the established sofosbuvir/velpatasvir fixed-dose combination in patients with chronic HCV infection. The dosing asymmetry embedded in the protocol carries direct manufacturing implications: BEM/RZR runs eight weeks in non-cirrhotic patients and 12 weeks in those with compensated cirrhosis, while the comparator arm runs a uniform 12 weeks. That differentiated duration profile will need to be reflected in commercial packaging configurations and labeling strategies ahead of any approval. The primary endpoint is HCV RNA below the lower limit of quantitation at 24 weeks from treatment initiation, encompassing SVR12 post-treatment in each arm.

The enrolled population spans a diverse range of HCV genotypes, including those more prevalent outside North America, a breadth that supports pursuit of a broad treatment label across multiple geographies. For regulatory affairs leads, that genotypic diversity also signals a filing strategy likely to engage multiple health authorities simultaneously, each with distinct ICH data package expectations and inspection readiness requirements for the manufacturing sites supplying trial and eventual commercial product.

Topline results from C-FORWARD are expected around year-end 2026. Results from the parallel North American C-BEYOND trial remain on track for mid-year 2026, meaning Atea could hold data from both pivotal studies within roughly six months. These are the first global Phase 3 head-to-head trials of direct-acting antivirals for HCV, a distinction that raises the evidentiary bar for comparator arms and places additional scrutiny on data integrity across a 17-country site network. HCV affects an estimated 50 million people globally, with US diagnoses continuing to outpace annual cure rates, sustaining the public health rationale for a next-generation regimen.

The convergence of C-FORWARD and C-BEYOND readouts in the second half of 2026 sets a firm timeline against which process validation, analytical method transfers, and CMO qualification activities will need to be substantially complete before regulatory submissions can proceed.

Source: Atea Pharmaceuticals, Inc. via GlobeNewswire, June 25, 2026.