On Wednesday, Atea Pharmaceuticals, Inc. AVIR released Phase 2 study data from the regimen of bemnifosbuvir and ruzasvir for the hepatitis C virus infection that causes liver swelling and can lead to serious liver damage.
The study met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).
Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with a regimen of bemnifosbuvir and ruzasvir.
The efficacy evaluable patient population, which included 17% treatment non-adherent patients, achieved a 95% (242/256) SVR12 rate demonstrating the potency and forgiveness of the regimen.
In June, Atea Pharmaceuticals shared new data from the lead-in cohort (n=60) of its ongoing Phase 2 combination study of bemnifosbuvir and ruzasvir for hepatitis C virus.
The regimen was generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations.
Full data for the Phase 2 study will be presented at a scientific meeting during the first half of 2025.
In the Phase 2 study, 99% (178/179) of treatment-adherent patients who were non-cirrhotic and infected with genotypes 1-4 achieved SVR12, demonstrating robust pan-genotypic potency and supporting an eight-week treatment in the Phase 3 program.
Treatment adherent patients with cirrhosis achieved a 88% (30/34) SVR12 rate.
Viral kinetics were slower in these cirrhotic patients. However, all patients achieved 100% end-of-treatment response. To maximize efficacy, the Phase 3 program will extend treatment duration to 12 weeks in patients with cirrhosis.
Atea is preparing for the Phase 3 program, which is expected to follow an End of Phase 2 meeting with the FDA anticipated for early 2025.
The Phase 3 program is expected to use a fixed-dose combination tablet, reducing the daily pill count from four to two tablets and enhancing patient convenience, with no food effect.
Price Action: AVIR stock is down 9.63% at $3.15 at the last check on Wednesday.
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