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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 announced the presentation of new modeling data predicting that the Company's combination regimen of bemnifosbuvir (BEM), a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, achieved near-complete inhibition of both viral replication and assembly and secretion into the bloodstream, with a modeled time to cure of approximately 7 to 8 weeks. These findings support the fixed-dose combination (FDC) regimen of BEM and RZR as a potential best-in-class, convenient, short-duration treatment of hepatitis C virus (HCV), further validating the Company's Phase 2 study results, which demonstrated that the combination regimen, after 8 weeks of treatment, achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) of 98% in the per-protocol treatment-adherent patient population and 95% in patients regardless of adherence. These modeling data will be presented at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 7-11 in Washington, DC.
The Company will also present two additional datasets: 1) a resistance analysis from the same Phase 2 study supporting the regimen's high barrier to resistance and 2) results from a Phase 1 study in healthy participants demonstrating the high relative bioavailability of the BEM/RZR FDC commercial formulation. These data also support dosing of the FDC with or without food or with famotidine (an H2 blocker which can substantially diminish the effectiveness of HCV oral antivirals). The FDC commercial formulation is being used in the ongoing Phase 3 program.
All results being presented underscore the regimen's potential best-in-class profile to address the needs of today's broad population of HCV patients. This includes those patients taking concomitant medications, who may need the flexibility of a treatment option that can be taken with or without food, or who present with resistant strains of HCV or advanced liver disease.
"Our goal has always been to develop a best-in-class regimen for HCV that meaningfully advances the standard of care for as many people as possible by addressing the evolving needs of today's HCV patients," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "These new findings reinforce the differentiated profile of our fixed-dose combination regimen of bemnifosbuvir and ruzasvir as a potent, pan-genotypic and convenient regimen with the potential to transform the treatment landscape and bring us closer to eradication of HCV."
Despite the availability of direct-acting antiviral therapies, HCV remains a significant public healthcare crisis in the US and globally with new diagnoses continuing to outpace cure rates. With a significant portion of the HCV patient population navigating co-infections or taking concomitant medications, an optimized, next-generation treatment option is needed to address their needs and meaningfully advance HCV eradication.
Posted In: AVIR
