Scientists from Veru Inc., an oncology biopharmaceutical company, found a novel COVID-19 drug reduces deaths by 55% in patients at high risk for Acute Respiratory Distress Syndrome (ARDS).
In the study, the team tested the drug in approximately 210 people with moderate to severe COVID-19 who were at high risk for ARDS and death.
Patients were assigned to the sabizabulin treatment group versus placebo.
Patients in both treatment groups were allowed to receive standard of care 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.
The results are based on an analysis of the first 150 patients randomized into the study. The primary efficacy endpoint was the proportion of patients that died by Day 60.
The team found the drug treatment resulted in a meaningful 55% reduction in deaths in the group.
Placebo group had a 45% mortality rate compared to the sabizabulin-treated group which had a 20% mortality rate. The secondary efficacy endpoints are still being analyzed at the time of this release.
The team also found that sabizabulin treatment was well tolerated in the patients.
The Company plans to meet with FDA to discuss next steps including the submission of an emergency use authorization application.
As previously disclosed, the FDA granted Fast Track designation to the sabizabulin COVID-19 clinical program in January 2022, which the Company hopes will help streamline the emergency use authorization process.
The team says scientists have battled this pandemic for almost two and a half years now.
A 55% reduction in deaths in hospitalized patients is tremendously meaningful to patients, their families, doctors, nurses, hospital staff and the communities they serve.
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