DewDiligence
6 months ago
AVIR phase-3 COVID trial failsโstock rises:
https://www.globenewswire.com/news-release/2024/09/13/2945844/0/en/Atea-Pharmaceuticals-Provides-Update-on-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Bemnifosbuvir-for-Treatment-of-COVID-19.html Atea Pharmaceuticals, Inc. (Nasdaq: AVIR)โฆtoday 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. This trial was a longshot insofar as Bemnifosbuvir is a repurposed HCV drug rather than something designed specifically for SARS-CoV-2. Moreover, the phase-2 trial for Bemnifosbuvir in COVID was unsuccessful, but AVIR plowed ahead anyhow.
I presume the share price is up slightly today because investors know that AVIR wonโt waste more money pursuing COVID. AVIR had about $475M of net current assets as of 6/30/24.
AVIRโs CEO, Jean-Pierre Sommadossi, is continuing to pursue a treatment regimen for HCV, which is a rather extreme case of Zebraโs Law (#msg-172559198).
DewDiligence
11 months ago
AVIR completes enrollment of phase-3 COVID trialโcancels 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 Pharmaceuticalsโฆtoday 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 cohortโฆ 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: โSince 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 2024โฆ