(RTTNews) - Atea Pharmaceuticals, Inc. (AVIR) a late-stage clinical biopharmaceutical company announced the completion of patient enrollment in its Phase 3 C-FORWARD trial evaluating Bemnifosbuvir and Ruzasvir in the treatment of Hepatitis C virus infection outside North America.
Company Profile
Atea Pharma focuses on developing anti-viral treatments for serious viral infections.
The company's lead program is the regimen of Bemnifosbuvir and Ruzasvir (BEM/RZR) for the treatment of Chronic hepatitis C virus (HCV) infection, which is currently in Phase 3 clinical trials. Atea is also advancing AT-587 as a potential therapy for hepatitis E virus (HEV).
Bemnifosbuvir and Ruzasvir (BEM/RZR)
Bemnifosbuvir is a nucleotide analog polymerase inhibitor, while ruzasvir is a non-structural protein 5A inhibitor. In a Phase 2 study, the combination regimen met its primary efficacy and safety endpoints and demonstrated pan-genotypic antiviral activity against HCV infection.
Hepatitis C virus (HCV)
HCV is a blood-borne, single-stranded (ss) RNA virus that infects the liver cells. It is a leading cause of chronic liver disease and liver transplantation and is primarily transmitted through blood transfusions and haemodialysis.
The company also estimates that in the U.S., more than 4 million people are estimated by the company to live with HCV, with a substantial proportion of patients between the ages of 20 and 49. There is an estimate of less than 10% of HCV patients who have cirrhosis.
C-FORWARD Trial Details
C-FORWARD is a Phase 3, open-label trial evaluating the safety and efficacy of the fixed-dose of BEM/RZR against a current standard of care (SOC) fixed-dose combination of Sofosbuvir and Velpatasvir (SOF/VEL) in naive patients with chronic HCV, primarily outside of North America.
In the study, the BEM/RZR regimen is administered once daily for 8 weeks in patients without cirrhosis or 12 weeks in patients with compensated cirrhosis, while sofosbuvir and velpatasvir are administered once daily for 12 weeks to all patients, regardless of cirrhosis status.
The primary endpoint of the trial is the proportion of patients achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment, encompassing sustained virologic response 12 weeks post-treatment (SVR12) in each arm.
C-FORWARD enrolled more than 880 treatment-naïve patients across approximately 120 clinical sites in 17 countries.
Near Term Milestones
The company expects to report topline Phase 3 C-FORWARD trial results by the end of 2026.
Atea noted that the similarly designed Phase 3 C-BEYOND trial, which is evaluating BEM/RZR in the US and Canada, remains on track for results in mid-year 2026. And topline results from the North American Phase 3 C-BEYOND trial are expected in mid-2026.
In addition, the company plans to submit a New Drug Application (NDA) for the BEM/RZR regimen for HCV in March 2027, subject to positive results from the Phase 3 C-BEYOND and C-FORWARD trials.
Atea has traded between $2.78 and $6.45 over the last year.
AVIR closed Thursday's trade at $4.35, down 2.58%.
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