Veru has reported interim analysis data from a Phase III clinical trial, where its oral Covid-19 drug candidate, sabizabulin, reduced mortality by 55% in hospitalised patients.
The double-blind, randomised, placebo-controlled trial is assessing once-daily dose of 9mg sabizabulin versus placebo in nearly 210 moderate-to-severe Covid-19 patients.
These subjects were admitted to the hospital and were at increased high risk of acute respiratory distress syndrome (ARDS) and death.
Carried out in the US, Brazil, Colombia, Argentina, Mexico and Bulgaria, the trial divided the subjects into a 2:1 ratio to receive sabizabulin or a placebo.
All the subjects in the treatment arm were given standard of care including remdesivir, dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors.
The proportion of subjects who died by day 60 was the primary efficacy endpoint of the trial.
According to the positive findings from the trial, treatment with sabizabulin provided a 55% clinically and statistically meaningful relative decline in mortality in the intent-to-treat population.
Furthermore, mortality rate of 45% and 20% were reported in the sabizabulin-treated and placebo arm, respectively.
Sabizabulin was found to be well tolerated in the trial subjects without any clinically significant safety issues reported in the sabizabulin arm versus placebo.
In addition, the Independent Data Safety Monitoring Committee of the trial advised halting the study early due to efficacy, with no safety concerns detected.
The company intends to hold talks with the US Food and Drug Administration on further steps including the filing of the application seeking emergency use authorization.
Veru president and CEO Mitchell Steiner said: “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 hospitalised patients with moderate to severe Covid-19.
“We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase III Covid-19 study, can be that greatly needed oral therapy for hospitalised moderate to severe Covid-19 patients.”
In March last year, the company announced plans to progress its drug, VERU-111, into a Phase III registration trial in hospitalised high-risk Covid-19 patients.