Atea Pharmaceuticals(AVIR) GlobeNewswire·2025-03-19 11:00Core Viewpoint - Atea Pharmaceuticals is advancing its clinical-stage antiviral drug bemnifosbuvir for the treatment of hepatitis C virus (HCV), with a Phase 3 program set to begin patient enrollment in April 2025, following positive Phase 2 results [1][4][5]. Group 1: Drug Development and Presentation - Atea presented preclinical data on bemnifosbuvir at the 38th International Conference on Antiviral Research, emphasizing the importance of cell model selection in evaluating antiviral efficacy [2][3]. - Bemnifosbuvir is being developed in combination with ruzasvir, a potent NS5A inhibitor, targeting chronic HCV infection [2][3]. Group 2: Phase 3 Program Details - The global Phase 3 program will include two open-label trials, one in the US and Canada and another outside North America, each enrolling approximately 800 treatment-naïve patients [5]. - The primary endpoint for both trials is sustained virologic response 12 weeks post-treatment (SVR12), with specific comparisons between the bemnifosbuvir/ruzavir regimen and existing treatments [6]. Group 3: Drug Efficacy and Safety - In vitro studies indicate that bemnifosbuvir is approximately 10-fold more active than sofosbuvir against various HCV strains and maintains potency against resistance-associated substitutions [7]. - Ruzasvir has shown potent antiviral activity and a favorable safety profile in clinical studies, supporting once-daily dosing [8]. Group 4: HCV Overview - HCV is a significant global health issue, with an estimated 50 million people chronically infected worldwide and approximately 242,000 deaths annually [9]. - In the US, between 2.4 and 4 million people are estimated to have HCV, with a predominance in the 20-49 age group and less than 10% having cirrhosis [9]. Group 5: Company Background - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging its expertise in antiviral drug development and nucleos(t)ide chemistry [10].