What happened
Shares of Veru (VERU +0.88%) soared 182% on Monday after the biopharmaceutical company announced promising clinical study results for sabizabulin, its oral drug candidate for COVID-19.
NASDAQ: VERU
Key Data Points
So what
An interim analysis of a phase 3 clinical trial showed that sabizabulin reduced the risk of death in hospitalized patients by 55%. These people had moderate to severe COVID-19 and were at high risk for acute respiratory distress syndrome (ARDS), an often-fatal condition in which fluid leaks into the lungs and prevents oxygen from getting to vital organs.
Better still, the drug was well tolerated by the roughly 210 patients in the study, with no clinically relevant safety events compared to placebo.
Image source: Getty Images.
In a press release, Veru 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 hospitalized patients with moderate to severe COVID-19.
Moreover, the drug appears to provide protection against multiple coronavirus variants, such as the highly contagious omicron strain. "What makes these findings more relevant is that the pharmacological activity of sabizabulin is independent of COVID-19 variant type," Veru Chief Scientific Officer Gary Barnette said.
Now what
Veru intends to apply for emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA granted Fast Track designation to sabizabulin in January, which could help to accelerate the EUA process.
Veru has ramped up its drug-manufacturing capabilities ahead of a potential authorization to meet what could be strong demand for its novel COVID-19 treatment. It has also begun negotiations with the U.S. government for an advance purchasing agreement for sabizabulin.
"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," Barnette said.
