Atea Pharmaceuticals Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment Milestone for Phase 3 SUNRISE-3 Trial for COVID-19

Core Insights - Atea Pharmaceuticals has achieved significant clinical milestones in its Hepatitis C Virus (HCV) and COVID-19 programs, reporting a 98% Sustained Virologic Response at Week 4 (SVR4) from the initial data of 52 patients in a Phase 2 study for HCV treatment and surpassing 650 patients enrolled in the Phase 3 SUNRISE-3 trial for COVID-19 [1][2][5] HCV Program - The Phase 2 study of bemnifosbuvir and ruzasvir (RZR) showed a 98% SVR4 rate, exceeding the efficacy criterion of >90% for continuing the study, with topline results expected in Q3 2024 [2][3] - The study enrolled 60 direct acting antiviral naïve, non-cirrhotic patients, with preliminary data available from 52 patients, indicating rapid viral load reduction and good tolerability of the treatment [3][4] - The trial aims to enroll approximately 280 treatment-naïve HCV-infected patients, with full enrollment expected by mid-2024 [4] COVID-19 Program - The SUNRISE-3 trial has enrolled over 650 patients, allowing for the first interim analysis by the independent Data Safety Monitoring Board (DSMB) expected in March 2024 [1][5] - This Phase 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating bemnifosbuvir in high-risk COVID-19 patients, with hospitalization as the primary endpoint [6][7] - The trial includes two study populations based on the type of standard of care received, with a primary endpoint of all-cause hospitalization or death through Day 29 post-treatment in 2,200 patients [8] Drug Mechanism and Efficacy - Bemnifosbuvir is a nucleotide polymerase inhibitor showing approximately 10-fold more activity than sofosbuvir against various HCV genotypes and remains effective against resistance-associated strains [9] - Ruzasvir has demonstrated potent antiviral activity in preclinical studies and has been well-tolerated in prior clinical trials [10] - For COVID-19, bemnifosbuvir targets the SARS-CoV-2 RNA polymerase, showing efficacy against all tested variants of concern [11] Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging its expertise in antiviral drug development and nucleos(t)ide chemistry [12][13]