Atea Pharmaceuticals provides update on global Phase 3 SUNRISE-3 study evaluating bemnifosbuvir for the treatment of COVID-19 Page 1

BOSTON, Sept. 13, 2024 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company discovering and developing oral antiviral therapeutics for severe viral diseases, today announced the result of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, compared to placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalizations or deaths 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 with the outcome of the SUNRISE-3 trial. COVID-19 variants are constantly evolving and the natural history of the disease has trended toward milder disease courses, resulting in fewer hospitalizations and deaths. Notably, no hospitalizations due to severe COVID-related respiratory illness were observed in SUNRISE-3, unlike our previous trial. In a setting where there is much less COVID-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate effects on disease progression,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “I am proud of our team's rigorous conduct of this trial in an ever-changing pandemic environment.”

“We would like to thank the study participants and researchers who made this important research possible. While we are disappointed with the outcome of the study and will not pursue a regulatory pathway, we believe the results contribute to the shared understanding of the evolution of COVID-19,” added Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals.

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

About the Phase 3 SUNRISE-3 study 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 concomitantly with locally available standard of care (SOC). SUNRISE-3 enrolled only high-risk outpatients with mild or moderate COVID-19 disease. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice daily (BID) or placebo twice daily for five days.