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Full Results from Phase 2 Study Confirmed 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) After Short 8-Week Treatment Duration for Regimen
Results from Phase 1 Study Showed Low Risk for Drug-Drug Interactions with Regimen When Co-Administered with Standard HIV Treatment Regimen
Bemnifosbuvir Was Generally Safe and Well Tolerated with No Dose Adjustment Needed
in Phase 1 Studies in Participants with Hepatic or Renal Impairment
Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, 2025
Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today presented results from the full cohort of patients (n=275) enrolled in its Phase 2 study evaluating the once-daily combination of bemnifosbuvir (BEM), an oral nucleotide NS5B polymerase inhibitor, and ruzasvir (RZR), an oral NS5A inhibitor, for the treatment of hepatitis C virus (HCV). The Phase 2 study met its primary endpoints of efficacy and safety. With a short 8-week treatment duration, the Phase 2 results showed a robust 98% (210/215) sustained virologic response rate at 12 weeks post-treatment (SVR12) with the regimen in the "Per-Protocol Treatment-Adherent Population." The SVR12 rate was 95% (245/259) in the "Per-Protocol Regardless of Adherence Population" (also referred to as the "efficacy evaluable population"), which included patients who were not treatment adherent (17%).
Results from three additional Phase 1 studies demonstrated that the combination of BEM/RZR had a low risk of drug-drug interactions (DDIs) and supported the safety of the regimen of BEM/RZR in patients co-infected with HCV and human immunodeficiency virus (HIV) taking a standard HIV treatment, and the safety of BEM in participants with hepatic or renal impairment with no need for dose adjustments.
These results were presented at the European Association for the Study of the Liver (EASL) Congress 2025 from May 7-10 in Amsterdam, Netherlands.
"The full results from the Phase 2 trial highlight the potential for our regimen to optimize the treatment of hepatitis C virus in all patients," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "Our potential best-in-class regimen, which has attributes of a short treatment duration, low risk for drug-drug interactions and convenience with no food effect, creates new opportunities to treat and cure an expanded number of HCV-infected patients, and we are eager to further explore these benefits in our C-BEYOND and C-FORWARD Phase 3 trials."
The Phase 2 study was conducted in treatment-naïve, chronic HCV-infected patients across genotypes either without cirrhosis (n=238) or with compensated cirrhosis (n=37). Results demonstrated 99% of treatment-adherent patients who were non-cirrhotic and infected with genotypes 1-4 achieved SVR12, demonstrating robust pan-genotypic potency and supporting an 8-week treatment duration in non-cirrhotic patients in the Phase 3 program. A 100% SVR12 rate was observed in non-cirrhotic, treatment-adherent patients infected with genotype 3, a historically difficult genotype to treat and cure.
"The average HCV patient we are treating today is quite different than several years ago – patients are more recently infected with fewer presenting with cirrhosis, and the majority are taking concomitant medications, including some that may not be recommended with the currently available HCV therapies," said Eric Lawitz, MD, The Texas Liver Institute, Clinical Professor of Medicine, University of Texas Health San Antonio. "I am encouraged by the complete Phase 2 results suggesting that the regimen of bemnifosbuvir and ruzasvir may offer a potent and more convenient option for my patients. I look forward to seeing the Phase 3 results when they are available."
Compensated cirrhosis was present in 13.5% (n=37) of the study participants and the SVR12 rate was 88% (30/34) in those who were treatment-adherent. Although viral kinetics were slower among patients with cirrhosis, all achieved HCV RNA
Between 2.4 to 4.0 million people in the US are living with chronic HCV, and an estimated 50 million people are infected worldwide. In the US, HCV diagnoses continually outpace cure rates annually. Today, as many as 80 percent of patients infected with HCV are taking concomitant medications1, creating a persistent need for a treatment option with robust potency, limited drug-drug interactions and a strong drug forgiveness profile.
Posted In: AVIR
