The oncology biopharma Veru Inc. (Nasdaq:VERU) revealed positive efficacy and safety data from an interim analysis of a Phase 3 trial testing oral sabizabulin 9 mg against placebo.
The trial enrolled 210 hospitalized COVID-19 patients with an elevated risk of acute respiratory distress syndrome (ARDS). The interim analysis focused on data collected from 150 of those patients.
The primary endpoint of the study was death at or before day 60.
The independent data safety monitoring committee overseeing the trial unanimously concluded that the study should be stopped early, given the apparent efficacy and the lack of identifiable safety concerns.
In the study, patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo.
The mortality rate of the placebo group was 45%, while the rate was 20% for the treatment group.
Both treatment arms were also permitted to receive standard of care treatments, including remdesivir, dexamethasone anti-IL6 receptor antibodies and Janus kinase (JAK) inhibitors.
“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,” said Dr. Mitchell Steiner, Veru CEO, in a press release.
Steiner noted that the company believes sabizabulin could be an important oral treatment option for hospitalized patients with moderate to severe COVID-19.
The company said sabizabulin promises to remain effective on all SARS-CoV-2 variants.
“Pending upcoming discussion with FDA, this treatment option may be made available soon so we can be ready for when the next clinically important wave of COVID infections comes,” said Gary Barnette, chief scientific officer of Veru.
Filed Under: Infectious Disease
