Atea Pharmaceuticals Inc AVIR reported initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination eight-week study of bemnifosbuvir and ruzasvir (RZR) for hepatitis C virus (HCV).
What Happened: The company says that the initial data from the Phase 2 combination eight-week study showed a 98% sustained virologic response at week four (SVR4), exceeding the company's efficacy criterion of >90% for continuing the study.
Additionally, very rapid kinetics were observed in all 60 patients across genotypes with viral load near or below the lower limit of quantification (LLOQ) at four weeks of treatment, which is supportive of an eight-week treatment regimen for the combination of bemnifosbuvir and RZR.
All 60 patients achieved viral load below the lower limit of quantification (LLOQ) at the end of the treatment. The combination was generally safe and well tolerated.
The Phase 2 study aimed to assess the safety and efficacy of eight weeks of treatment with the combination of bemnifosbuvir and RZR in treatment-naïve HCV-infected patients, either without cirrhosis and or with compensated cirrhosis. The primary endpoint of the study is SVR12.
Read Also: Sarepta Expects Prelim Gene Therapy Revenue To Be $131M In Q4, $200M For Fiscal Year
Why It Matters: Approximately 280 treatment-naïve HCV-infected patients are expected to be enrolled in the Phase 2 study. The trial's second part is anticipated to enroll 220 patients across all genotypes. Full enrollment of the study is expected to be completed by mid-2024, with topline results in the third quarter of 2024.
Additionally, Atea has enrolled more than 650 patients in the monotherapy arm of its Phase 3 SUNRISE-3 trial for COVID-19, and enrollment continues with the current wave.
This enrollment milestone allowed for the first interim analysis of the study by the DSMB, which is expected this March.
Patients are randomized 1:1 to receive either bemnifosbuvir 550 mg twice daily (BID) or placebo BID for five days, with hospitalization as a primary endpoint.
William Blair emphasized that although there is a noticeable increase in public indifference towards COVID-19, the market potential for COVID-19 oral antiviral treatments continues to be substantial, reaching into the multibillion-dollar range.
This presented a significant opportunity for Atea, particularly due to factors such as declining immunity, the emergence of new virus variants, and reduced reliance on vaccines.
AVIR Price Action: Atea Pharmaceuticals shares are up 9.02% at $3.38 on the last check Tuesday.
Read Next: Short Seller's Bombshell Report Rattles Grifols: Stock Chart Points To Potential Further Decline
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
date | ticker | name | Price Target | Upside/Downside | Recommendation | Firm |
|---|
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
