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Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
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
About this update from Veru Inc.
[{"type":"text","content":"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 Enrollment is expected to initiate in the second half of 2023 and the first planned interim efficacy analysis expected in 2024 MIAMI, FL, May 04, 2023 (GLOBE NEWSWIRE) -- 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. Highlights from the April 27th FDA meeting FDA agreed to a confirmatory Phase 3, randomized (1:1), multicenter, global, efficacy and safety study of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in 408 hospitalized adult patients with moderate to severe SARS-CoV-2 infection who are at high risk for ARDS: Indication (patient population) for sabizabulin has been expanded to include all hospitalized moderate to severe COVID-19 patients: WHO-4 (passive, low flow oxygen), WHO-5 (forced, high flow oxygen), or WHO-6 (mechanical ventilation) without a requirement to have a comorbidity.Endpoints: Primary efficacy endpoint is all-cause mortality at Day 60Secondary endpoints include Days in the hospital, Days in the ICU, Days on mechanical ventilation,...