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

A 98% Sustained Virologic Response at Week 4 (SVR4) Post-Treatment Observed in Initial Data From 52 Patients in Lead-In Cohort in Phase 2 HCV Study

Phase 3 SUNRISE-3 Enrollment Surpassed 650 Patients in Monotherapy Arm; First Interim Analysis by the Independent Data Safety Monitoring Board (DSMB) Expected in March 2024

BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the achievement of two significant clinical milestones from its Hepatitis C Virus (HCV) and COVID-19 programs. The Company reported positive initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination 8-week study of bemnifosbuvir and ruzasvir (RZR) for the treatment of HCV. Additionally, Atea has enrolled more than 650 patients in the monotherapy arm of its Phase 3 SUNRISE-3 trial for the treatment of COVID-19, and enrollment continues with the current wave. This enrollment milestone allows for the first interim analysis of the study by the DSMB, which is expected this March.

Initial Phase 2 Data for HCV Combination Study

“We are excited to share that the initial data from the Phase 2 combination 8-week study showed a 98% SVR4, which exceeds our efficacy criterion of >90% for continuing the study. Based on these data, we plan to imminently reinitiate enrollment to complete the Phase 2 study and topline results are anticipated in the third quarter of 2024,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “While direct acting antivirals have transformed HCV treatment, substantial unmet needs still exist, and the rate of new and reinfection currently exceeds cure rates in the US where 2.4 million individuals are estimated to be infected. The key unmet needs identified by healthcare providers in market research recently conducted by Atea include shorter length of treatment with fewer contraindications, particularly drug-drug interactions.”

The Phase 2 open label study of bemnifosbuvir and RZR enrolled a lead-in cohort of 60 direct acting antiviral naïve, non-cirrhotic patients across all genotypes. Patients were administered 550 mg of bemnifosbuvir in combination with 180 mg of RZR once-daily for 8 weeks. Preliminary data are being presented as available, with SVR4 data currently available from 52 of the 60 lead-in patients. Including SVR4 as a decision endpoint, is a study design that is intended to substantially shorten the anticipated timeline for the completion of the Phase 2 trial. Clinical trials of other direct acting antiviral therapy combinations have demonstrated that the SVR4 result is highly correlated with SVR12.