Veru's Cancer Candidate Sabizabulin Gets FDA Fast Track Tag For COVID-19

The FDA has granted Fast Track designation to Veru Inc's VERU sabizabulin, oral cytoskeleton disruptor, to combat COVID-19 infection and the cytokine storm responsible for Acute Respiratory Distress Syndrome (ARDS) and death. 

• Sabizabulin disrupts microtubule intracellular transport of the coronavirus, a process that new COVID-19 variants or strains will still require to cause infection. 
• The Company notes that there have been recent developments evaluating Merck & Co Inc's MRK molnupiravir and Pfizer Inc's PFE Paxlovid for unhospitalized patients with mild to moderate COVID-19, sabizabulin is being developed for hospitalized patients with a high risk of death. 
• In Phase 2 study in hospitalized COVID-19 patients at risk for acute respiratory distress syndrome, sabizabulin treatment resulted in an 82% relative reduction in death compared to placebo. 
• The Company is enrolling 300 hospitalized patients in Phase 3 study with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome. 
• Clinical results are expected in 1H of calendar 2022.
• The Company is also evaluating sabizabulin in breast cancer settings.
• Price Action: VERU shares are up 9.28% at $5.18 during the market session on the last check Monday.