Atea Pharmaceuticals, Inc.（AVIR）资讯与事件AVIRAtea Pharmaceuticals, Inc.

Atea Pharmaceuticals C-BEYOND Trial Shows BEM/RZR Non-Inferior to SOF/VEL

Atea Pharmaceuticals announced topline results from C-BEYOND, its Phase 3 trial conducted in North America evaluating the once-daily fixed-dose combination of bemnifosbuvir and ruzasvir for the treatment of chronic hepatitis C virus infection. BEM/RZR demonstrated statistical non-inferiority compared to the fixed-dose combination of sofosbuvir and velpatasvir in the modified intent-to-treat population, achieving the trial's primary endpoint. C-BEYOND enrolled patients reflective of the current real-world population living with HCV in the US and Canada. In the mITT analysis, BEM/RZR achieved a 93.9% sustained virologic response rate vs. 94.8% for SOF/VEL at Week 24, encompassing SVR at 12 weeks post-treatment in both arms. These results achieved the primary endpoint of statistical non-inferiority, with a 95% confidence interval for difference in SVR rates within the prespecified 5% margin. The mITT analysis in patients without cirrhosis showed BEM/RZR achieved a 93.5% SVR rate vs. 94.6% for SOF/VEL. In patients with cirrhosis, BEM/RZR achieved a 95.4% SVR rate vs. 95.4% for SOF/VEL. In C-BEYOND, rates of virologic failure across all populations were low and comparable between treatment arms. Statistical non-inferiority was also met in secondary endpoints, including the per-protocol analysis. BEM/RZR was administered as an 8-week regimen to patients without cirrhosis compared with the 12-week regimen of SOF/VEL, highlighting the potential of BEM/RZR to deliver robust antiviral efficacy with a shorter treatment duration. In the US, approximately 80-90% of people living with HCV do not have cirrhosis. Together with its potential advantages of a shorter treatment duration for most patients, low risk of drug-drug interactions and no food effect, the results from C-BEYOND further reinforce BEM/RZR's potential as a differentiated, best-in-class treatment option for people with HCV. In C-BEYOND, BEM/RZR demonstrated robust SVR rates across HCV genotypes that predominate in North America. C-FORWARD, which is being conducted outside North America, includes a broader range of HCV genotypes and is expected to provide additional efficacy data in genotypes more frequently found outside the US and Canada. In C-BEYOND, BEM/RZR was generally safe and well tolerated with no drug-related serious adverse events or drug related early treatment discontinuations. Safety was comparable between treatment arms. C-BEYOND was conducted at approximately 120 sites in the US and Canada. C-FORWARD, which is fully enrolled with more than 880 patients, is being conducted at approximately 120 sites in 17 countries outside North America and is on track to report topline results in early 2027. Atea plans to present the detailed results of its global Phase 3 program in HCV at future medical conferences and submit to peer-reviewed medical journals for publication.

Atea Pharmaceuticals Initiates First-in-Human Trial for AT-587

Atea Pharmaceuticals announced the initiation of a first-in-human Phase 1 clinical trial evaluating AT-587, for the treatment of hepatitis E virus infection. AT-587 is a proprietary oral antiviral nucleotide analog being developed for the treatment of HEV, a potentially serious liver disease that can lead to chronic infection, cirrhosis and liver failure in certain patient populations.

Atea Pharmaceuticals Completes Patient Enrollment in C-FORWARD Clinical Trial

Atea Pharmaceuticals announced completion of patient enrollment in C-FORWARD, its Phase 3 clinical trial outside North America, evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus infection. The anticipated topline results from C-BEYOND, the Phase 3 trial conducted in the US and Canada, remain on track for mid-year 2026.