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New England Journal of Medicine Evidence publication of phase III clinical trial results demonstrating that sabizabulin treatment significantly reduced deaths in high-risk hospitalized COVID-19 patients.

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Published:7th Jul 2022

Veru Inc. announced the publication of the results from a Phase III 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 III 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 III 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 statistically meaningful 55.2% relative reduction in deaths (p=0.0042) in the intent to treat population (ITT). At Day 60, the placebo group (n = 52) had a 45.1% mortality rate compared to the sabizabulin-treated group (n = 98) which had a 20.2% mortality rate. In the overall study of 204 randomized patients, the reduction in the all-cause mortality (ITT population) was similar to the results observed in the interim efficacy analysis patient population with sabizabulin treatment resulting in a 51.6% reduction in deaths compared to the placebo group.

The key secondary endpoints included effects of sabizabulin treatment on mortality through Day 29, with a placebo mortality rate of 35.3% compared to sabizabulin treatment mortality rate of 17%, sabizabulin treatment resulted in an absolute reduction of 18.3 percentage points and a relative reduction in deaths of 51.8%. Sabizabulin treatment also resulted in a 43% relative reduction in days in ICU (p=0.0013), 49% relative reduction in days on mechanical ventilation (p=0.0013), and 26% relative reduction in days in hospital (p=0.0277) compared to placebo group. Adverse and serious adverse events were lower in the sabizabulin group compared to the placebo group.

See- "Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis"- K. Gary Barnette, Ph.D., Michael S. Gordon, M.D. et al.,for the Phase III COVID-19 Investigators*. Published July 6, 2022. DOI:https://doi.org/10.1056/EVIDoa2200145.

Condition: Coronavirus/ARDS
Type: drug

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