Enrollment Completed in C-BEYOND Phase 3 Trial with More Than 880 HCV Treatment-Naïve Patients in US and Canada
Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, announced completion of enrollment of more than 880 treatment-naïve patients in the C-BEYOND Phase 3 trial evaluating the fixed-dose combination (FDC) regimen of bemnifosbuvir and ruzasvir compared to the FDC regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV). C-BEYOND is being conducted at approximately 120 clinical trial sites in the US and Canada. Phase 3 topline results are expected mid-year 2026.
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In addition to C-BEYOND, Atea continues to advance enrollment of treatment-naïve patients in C-FORWARD, a Phase 3 trial evaluating this same FDC regimen in 880 patients at approximately 120 clinical trial sites in up to 17 countries outside of North America. Completion of enrollment in C-FORWARD is expected mid-year 2026, with Phase 3 topline results anticipated year-end 2026. In both studies, the FDC regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the comparator FDC regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks.
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“Completing enrollment in C-BEYOND marks a critical inflection point in our Phase 3 HCV program and we are on track to deliver topline results from this trial mid-2026,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “Our goal is and has always been to develop a best-in-class HCV treatment that meaningfully advances the standard of care. We believe that the target profile of our regimen — featuring short treatment duration, low risk of drug-drug interactions and convenience with no food effect — will uniquely position us to address the evolving needs of today’s patients and bring us closer to the ultimate goal of HCV eradication.”
HCV continues to be a significant global health burden despite the availability of direct-acting antivirals (DAAs). Up to 4 million people in the US are living with chronic HCV, and an estimated 50 million people are infected worldwide with approximately one million new infections occurring each year. In the US, HCV diagnoses continue to outpace annual cure rates. According to healthcare providers who treat patients with HCV, approximately 80 percent of HCV patients take multiple medications to manage comorbidities and coinfections and concerns related to currently approved HCV therapeutics and drug-drug interactions are a significant factor in HCV treatment delay. As a result, a new treatment option offering high efficacy, short treatment duration, and a low risk of drug-drug interactions could meaningfully help to address patient needs and further the goal of HCV eradication.
About the C-BEYOND and C-FORWARD Phase 3 Trials in Adults with Chronic HCV
Atea’s HCV development program includes two open-label Phase 3 trials, C-BEYOND conducted in the US and Canada, and C-FORWARD conducted outside of North America. Each trial is enrolling approximately 880 treatment-naïve patients, including those with or without compensated cirrhosis. The trials compare the FDC regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir an NS5A inhibitor, to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis.
The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients.
About HCV
HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, up to 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
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Source- GlobeNewswire
