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Veru Announces Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022
MIAMI, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other
About this update from Veru Inc.
[{"type":"text","content":"MIAMI, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced data from the late-breaker oral presentation of the Phase 3 trial of sabizabulin treatment for hospitalized adults with COVID-19 who required supplemental oxygen at IDWeek (Infectious Disease Week) 2022, which took place October 19-23, 2022, in Washington, D.C. “The death rate of hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS remains unacceptably high despite the current standard of care. We are excited to present positive clinical data from the pivotal Phase 3 COVID-19 study subset analysis of hospitalized COVID-19 patients who required supplemental oxygen and had at least one comorbidity. This compelling data demonstrated that treatment with sabizabulin, an antiviral and anti-inflammatory agent, led to statistically and clinically meaningful reductions in clinical progression and deaths,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Sabizabulin’s mechanism of action, both in blunting the inflammatory response and preventing viral replication at the host level, could be a really important tool in our fight against COVID-19, especially given sabizabulin’s ability to work in COVID-19 variants of concern. Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients,” said Paula Skarda, M.D. – Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota, a lead investigator in Veru’s Phase 2 and Phase 3 clinical trials of sabizabulin. Presentation HighlightsSabizabulin is an oral, novel microtubule disruptor with dual antiviral and anti-inflammatory activities. A randomized, multicenter placebo-controlled Phase 3 clinical trial was conducted in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS) and death. Patients were randomized (2:1) to sabizabulin 9 mg or placebo oral daily dose (up to 21 days or discharge from hospital). The primary endpoint was all-cause mortality up to day 60. Key secondary endpoints were days in intensive care unit (ICU), on mechanical ventilation, and in hospital. Randomi...