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Veru Reaches Agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication: Hospitalized Adult Patients with Any Type of Viral Acute Respiratory Distress Syndrome (ARDS)
--Reached agreement with FDA on single Phase 3 clinical trial design to expand treatment population to include all hospitalized adult patients with any type
About this update from Veru Inc.
[{"type":"text","content":"--Reached agreement with FDA on single Phase 3 clinical trial design to expand treatment population to include all hospitalized adult patients with any type of virus induced ARDS including the “tripledemic viruses”: Influenza, RSV, and SARS-CoV-2-- -- Based on high mortality rate for viral ARDS, expected sabizabulin Phase 3 study size is 408 patients with all-cause mortality at Day 60 as the primary endpoint-- --The Company plans to conduct the “all comers” viral ARDS Phase 3 study instead of the second confirmatory Phase 3 COVID-19 study-- -- Enrollment could begin as early as calendar Q4 2023-- MIAMI, FL, Sept. 26, 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 viral induced ARDS, today announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase 3 clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS. The Phase 3 study may suffice as a single study for NDA submission. Highlights from the September 21st FDA meeting FDA agreed to a Phase 3, randomized (1:1), multicenter, placebo-controlled, parallel group design study to evaluate the efficacy and safety of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in hospitalized adult patients with any type of virus inducing ARDS: Novel indication (patient population) for sabizabulin has been expanded to include all hospitalized adult patients with any type of viral induced ARDSEndpoints: Primary efficacy endpoint is all-cause mortality at day 60Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, and proportion of patients alive without respiratory failure Given the high mortality rate for viral induced ARDS (27-45%), the expected size of the study is 408 patientsIf Phase 3 study were to demonstrate sufficient benefit on all-cause mortality at Day 60, then this study could potentially be sufficient for NDA submissionAs the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin \"As sabizabulin has broad host directed antiv...