On Friday, Atea Pharmaceuticals Inc. (NASDAQ:AVIR) announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for 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," said Jean-Pierre Sommadossi, CEO and Founder of Atea Pharmaceuticals.
"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," Sommadossi added.
Atea remains focused on developing the combination of bemnifosbuvir and ruzasvir for hepatitis C.
In June, Atea Pharmaceuticals released new data from the lead-in cohort (n=60) of the company's ongoing Phase 2 combination study of bemnifosbuvir for hepatitis C.
The company plans to announce additional results from the Phase 2 trial in the fourth quarter of 2024.
With an eight-week treatment duration in 60 patients, the Phase 2 data from the lead-in cohort of non-cirrhotic patients showed a 97% sustained virologic response rate at 12 weeks post-treatment, the study's primary efficacy endpoint.
Price Action: AVIR stock is up 3.41% to $3.80 at the last check on Friday.
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