Atea Pharmaceuticals has announced positive results from its Phase 2 clinical trial evaluating a combination regimen of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus (HCV). The study met its primary endpoints, demonstrating high efficacy and a favorable safety profile, paving the way for a Phase 3 program expected to begin in early 2025.
The Phase 2 study enrolled 275 treatment-naïve patients, including those with and without compensated cirrhosis. The results showed a 98% sustained virologic response at 12 weeks post-treatment (SVR12) in patients who adhered to the eight-week treatment protocol. In the efficacy-evaluable patient population, which included some non-adherent patients, the SVR12 rate was 95%. The regimen was reported to be generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations.
Robust Efficacy Across Genotypes
Specifically, among non-cirrhotic, treatment-adherent patients infected with genotypes 1-4 of the virus, 99% achieved SVR12. Patients with cirrhosis achieved an 88% SVR12 rate; however, all cirrhotic patients showed a 100% end-of-treatment response. Atea plans to extend the treatment duration to 12 weeks for cirrhotic patients in the Phase 3 study to maximize efficacy.
"These high SVR12 results with only eight weeks of treatment with our regimen are extremely exciting and very significant given the unmet needs for today’s HCV patients," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "We believe that this regimen has the potential to play a major role in the eradication of HCV in the U.S."
Simplified Regimen for Phase 3
Atea is preparing to initiate a global Phase 3 program in early 2025, following discussions with regulatory authorities, including the U.S. Food and Drug Administration (FDA). The Phase 3 program is expected to simplify the regimen further by reducing the daily pill count from four to two in a fixed-dose combination tablet, enhancing patient convenience.
Addressing Unmet Needs in HCV Treatment
Despite available direct-acting antivirals, HCV remains a significant global health issue, with an estimated 50 million people chronically infected worldwide. In the U.S., new infections outpace treatment rates annually. Atea aims to address the unmet needs of HCV patients with a convenient, short-duration treatment option that has a low risk of drug-drug interactions.
"Our regimen has a potential best-in-class profile that includes the key features for successfully treating today’s HCV patients including convenience, low risk for drug-drug interactions and short treatment duration," Sommadossi added.
Financial Outlook
Atea's financial stability appears solid, with a cash reserve of $482.8 million projected to provide stability through at least 2027. The company's strategic focus has shifted towards the HCV program after challenges with its COVID-19 treatment trials.
