Atea Pharmaceuticals Provides Update on Global Phase 3 SUNRISE-3 Trial Evaluating Bemnifosbuvir for Treatment of COVID-19

BOSTON, Sept. 13, 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 outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated.

“We are disappointed by the outcome of the SUNRISE-3 trial. Variants of COVID-19 are constantly evolving and the natural history of the disease trended toward milder disease, which has resulted in fewer hospitalizations and deaths. In particular, hospitalization due to severe respiratory disease caused by COVID was not observed in SUNRISE-3, in contrast to our prior study. In an environment where there is much less COVID-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate impact on the course of the disease,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “I am proud of our team’s rigorous execution of this trial in a constantly changing pandemic environment.”

“We want to thank the study participants and investigators who made this important research possible. While we are disappointed with the outcome of trial and will not pursue a regulatory pathway forward, we believe that the findings add to the collective understanding of the evolution of COVID-19,” added Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals.

Atea remains focused on the development of the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C. The company plans to announce additional results from the Phase 2 trial in the fourth quarter of 2024.

About the Phase 3 SUNRISE-3 Trial in High-Risk Outpatients with COVID-19

The global, multicenter, randomized, double-blind, placebo-controlled Phase 3 SUNRISE-3 trial evaluated bemnifosbuvir or placebo administered concurrently with the locally available standard of care (SOC). SUNRISE-3 exclusively 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.