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 Highlights
Sabizabulin 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. Randomization was stratified by oxygen requirement at baseline (WHO 4 = supplemental oxygen, WHO 5 = NIV/forced oxygen, WHO 6 = mechanical ventilation). In a planned interim analysis, sabizabulin treatment resulted in a 55.2% relative reduction in mortality compared to placebo.
In a post hoc subset analysis, in COVID-19 patients who had at least one comorbidity and required supplemental oxygen, the baseline characteristics were similar between the sabizabulin and placebo groups. In this WHO 4 subset group, sabizabulin treatment resulted in statistically and clinically significant reductions in mortality as well as days in the ICU, on mechanical ventilation, and in the hospital. Sabizabulin treatment resulted in a 22.4 absolute percentage point and 81.2% relative reduction in deaths compared to the placebo (odds ratio 6.22, 95% CI [1.58 to 24.48], p=0.0090). Sabizabulin treatment resulted in relative reductions of 74.7% in days in ICU (p=0.0021), 80.7% in days on mechanical ventilation (p=0.0019), and 39.8% in days in hospital (p=0.0191) vs. placebo. Sabizabulin had a good safety profile and was well tolerated.
Presentation Details:
Presentation Title: (LB1530) Clinical Benefit of Oral sabizabulin for Hospitalized Adults with CoVID-19 on Supplemental Oxygen
Abstract Number: 1329811
Presenter: Paula Skarda, M.D. – Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota
Session Title: COVID-19 Late Breaking Abstracts
Presentation Date and Time: Friday October 21, 2022 | 2:05 PM – 2:15 PM ET
Presentation Location: 209 ABC |
