Atea Pharmaceuticals Completes Patient Enrollment in Global Phase 3 SUNRISE-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients

Enrollment Reached Over 2,200 High-Risk Patients in Bemnifosbuvir Monotherapy Cohort

Results from SUNRISE-3 Expected in 2H’24

BOSTON, March 27, 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 that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort. The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients. Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.

“COVID-19 continues to be a threat, leaving the most vulnerable at risk for severe outcomes from infection. The rapid pace of enrollment recently experienced in the monotherapy cohort of SUNRISE-3 highlights the continuing unmet medical need for new oral COVID-19 treatment options for high-risk patients, such as the elderly, immunocompromised and those with underlying risk factors,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “Since full enrollment was achieved ahead of the two planned interim analyses for safety and futility by the Data Safety Monitoring Board (DSMB), the analyses are no longer relevant, and in agreement with the DSMB, we will proceed to the full analysis of the trial. We look forward to reporting SUNRISE-3 results in the second half of 2024 with the goal of moving a step closer to providing a new oral antiviral treatment for people at high risk for COVID-19 progression.”

Bemnifosbuvir was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of COVID-19.

About the Phase 3 SUNRISE-3 Trial

The global, multicenter, randomized, double-blind, placebo-controlled Phase 3 SUNRISE-3 trial is evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC). SUNRISE-3 enrolled high-risk outpatients with mild or moderate COVID-19. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice daily (BID) or placebo BID for five days.