The first oral medicine for severe COVID-19: Veru submits sabizabulin EUA to FDA
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The first oral medicine for severe COVID-19: Veru submits sabizabulin EUA to FDA.
On June 7, Veru announced that it has submitted an Emergency Use Authorization Application (EUA) to the FDA for sabizabulin (bisindole) for the treatment of patients hospitalized with moderate to severe COVID-19.
Sabizabulin is an oral bisindole developed by Veru that binds to the “colchicine binding sites” of alpha and beta tubulin and inhibits tubulin polymerization at low nanomolar concentrations. By inhibiting tubulin, it blocks the intracellular transport of SARS-CoV-2 along microtubules.
At the same time, the drug has anti-inflammatory effects and can prevent the cytokine storm caused by the new coronavirus infection.
On April 11 this year, Veru announced the Phase III clinical data of Sabizabulin, which aims to evaluate the efficacy and safety of the drug in the treatment of patients with moderate to severe COVID-19 pneumonia who are at risk of acute respiratory distress syndrome (ARDS) and death.
The study included approximately 210 subjects who were randomized 2:1 to receive sabizabulin (9 mg orally once daily) and placebo.
Data from the interim analysis of the first 150 patients enrolled showed a mortality rate of 45% in the placebo group (n=52) and 20% in the sabizabulin group (n=98). Sabizabulin reduced the relative risk of death in patients by 55% (p = 0.0029), which was clinically and statistically significant. Daily oral sabizabulin was well tolerated with a similar safety profile compared to placebo. Secondary endpoints are under analysis.
Shares of Veru have risen more than 260% since April.
In addition to Covid-19, Sabizabulin has also been developed for the treatment of castration-resistant prostate cancer, triple-negative breast cancer, HR-positive breast cancer, and more.
The first oral medicine for severe COVID-19: Veru submits sabizabulin EUA to FDA
(source:internet, reference only)
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