Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin ...
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced that in an April 27, 2023 meeting, the Company and FDA reached agreement on the design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin treatment in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS) and the path forward to submit a new Emergency Use Authorization (EUA) application and/or New Drug Application (NDA). Based on the FDA's positive feedback on the confirmatory Phase 3 clinical study design and program, the Company anticipates initiating the clinical study in the second half of 2023
By Veru Inc.
Published - May 04, 2023, 08:33 AM ET
Last Updated - May 02, 2024, 02:30 PM EDT
Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60
Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities
Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for efficacy
If confirmatory Phase 3 clinical trial meets statistical significance, Veru may consider submission of a new request for EUA and/or NDA
