Independent safety monitors recommended stopping a phase 3 clinical trial early due to "overwhelming evidence of efficacy" after finding a new drug, sabizabulin, cut the death rate among severe COVID-19 patients by 55 percent, the drug's developer, Veru, announced April 11.
The findings have not yet been peer-reviewed. The independent safety committee's decision to recommend the late-stage trial be stopped is based on findings from 150 people hospitalized with COVID-19 who were at high risk for acute respiratory distress syndrome and death. Among 52 people in the placebo group who received a standard of care treatment or dummy pill, the death rate was 45 percent within 60 days, compared to 20 percent among 98 people who received sabizabulin. No safety concerns were identified during the trial, according to Veru.
The drug, meant only for hospitalized patients, was administered once per day as a 9-milligram capsule. Veru's CEO, Mitchell Steiner, MD, told The New York Times the company plans to meet with the FDA later this month to discuss next steps and will be applying for emergency-use authorization. The agency previously granted sabizabulin fast-track status, a designation meant to streamline development and review of new treatments that address unmet medical needs or target serious conditions.
"This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19," Dr. Steiner said in a statement.