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Re: DewDiligence post# 63

Wednesday, 03/27/2024 11:37:22 AM

Wednesday, March 27, 2024 11:37:22 AM

Post# of 65
AVIR completes enrollment of phase-3 COVID trial—cancels interim analyses:

https://www.globenewswire.com/news-release/2024/03/27/2853010/0/en/Atea-Pharmaceuticals-Completes-Patient-Enrollment-in-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Oral-Antiviral-Bemnifosbuvir-for-COVID-19-in-High-Risk-Patients.html

Atea Pharmaceuticals…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… 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.

The two planned interim analyses have been canceled:

“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…


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