Veru has reported positive findings from the Phase II clinical trial of oral sabizabulin in individuals with severe Covid-19 who are at increased risk for acute respiratory distress syndrome (ARDS).
The latest phase II data support advancing sabizabulin to Phase III development. According to the findings, treatment with sabizabulin offered an 82% relative decline in deaths in subjects with severe Covid-19.
In addition, the oral therapy led to a 73% relative decline in mean days in the intensive care unit (ICU) versus placebo.
Sabizabulin treatment provided a decline in mean days on mechanical ventilation of 1.2 ± 6.06 days versus 5.1 ± 11.24 days in the placebo arm, indicating a 78% relative decline.
In the trial, sabizabulin was found to be safe and well-tolerated without any treatment-associated adverse events reported.
An oral cytoskeleton disruptor, sabizabulin possesses anti-viral as well as anti-inflammatory properties.
The randomised, double-blind, placebo-controlled trial analysed oral once-daily dose of sabizabulin compared to placebo in nearly 40 hospitalised Covid-19 patients at increased ARDS risk.
It was carried out in five trial centres in the US and subjects were given sabizabulin or a placebo, in addition to standard of care for 21 days or until discharge from the hospital.
The proportion of subjects alive without respiratory failure at day 29 was the trial’s primary efficacy endpoint.
Veru chairman, president and CEO Mitchell Steiner said: “We are very excited about the clinically meaningful reduction in deaths in hospitalised Covid-19 patients at high risk for ARDS and death being presented from this Phase II study.
“The clinically meaningful and statistically significant reduction in deaths in this high risk population was confirmed in a Phase III Covid-19 study which was stopped for overwhelming efficacy based on a planned interim analysis.”
The latest development comes after the company reported interim analysis data from a Phase III trial, where sabizabulin lowered mortality by 55% in hospitalised patients.