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Veru Announces New England Journal of Medicine Evidence Publication of Phase 3 Clinical Trial Results Demonstrating that Sabizabulin Treatment Significantly Reduced Deaths in High-Risk Hospitalized COVID-19 Patients
- Phase 3 Clinical Study Met Primary and Key Secondary Endpoints - - Primary Endpoint: Sabizabulin Treatment Showed Statistically Significant and Clinically
About this update from Veru Inc.
[{"type":"text","content":"- Phase 3 Clinical Study Met Primary and Key Secondary Endpoints - - Primary Endpoint: Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55.2% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized COVID-19 Patients - - Key Secondary Endpoints: Sabizabulin Treatment had Significant and Clinically Meaningful Reduction in Days in ICU, Days on Mechanical Ventilation, and Days in the Hospital -- Sabizabulin was Well Tolerated with a More Favorable Safety Profile Compared to Placebo - - Company Submitted Request for Emergency Use Authorization to FDA on 6/7/22 - MIAMI, July 06, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced the publication of the results from a Phase 3 COVID-19 study evaluating the efficacy and safety of oral sabizabulin, a novel dual antiviral and anti-inflammatory agent, for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death in The New England Journal of Medicine (NEJM) Evidence. The Phase 3 COVID-19 clinical trial is a double-blind, randomized, multicenter, and global placebo-controlled study evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients (≥ WHO 4, supplemental oxygen) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. Patients in both treatment groups were allowed to receive standard of care treatment including remdesivir, dexamethasone, anti-IL6 receptor antibodies, and JAK inhibitors. The trial was conducted in the United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria. COVID-19 infections treated in the study included the Delta and Omicron variants. A planned interim analysis was conducted in the first 150 patients randomized into the study. The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to clear efficacy benefit. For the primary efficacy endpoint, which was death at or before day 60, sabizabulin treatment resulted in a clinically and stat...