UT Research Foundation licensee Veru, Inc. announced on April 11, 2022, that their Phase 3 clinical trial of sabizabulin as an oral therapy for hospitalized severe COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS) and death showed the drug to be safe and effective. The trial was halted early due to the positive efficacy results, and the company announced that it will seek emergency use authorization from the FDA to bring their drug product to market.
The key contributors from the University of Tennessee Health Science Center included Dr. Wei Li, UTHSC Distinguished Professor in the Department of Pharmaceutical Sciences and Director of the UTHSC College of Pharmacy Drug Discovery Center; and Dr. Duane D. Miller, Professor Emeritus in the UTHSC Department of Pharmaceutical Sciences. Both Drs. Li and Miller were involved in the initial design and testing of sabizabulin, working in collaboration with scientists at Ohio State University and GTx Inc. Initial in vitro testing of sabizabulin for this antiviral use was conducted at the UTHSC Regional Biocontainment Lab by Dr. Colleen Jonsson, Professor and Van Vleet Chair of Excellence in Virology and Director of the Regional Biocontainment Laboratory (RBL). Demonstration that sabizabulin had anti-inflammatory activity was performed in a septic shock mouse model by the laboratory of the late Professor Arnold Postlethwaite, MD, AB, former Goodman Chair of Excellence Professor of Medicine and director of the Division of Connective Tissue Diseases at the University of Tennessee Health Science Center.
The Phase 3 trial of sabizabulin as a treatment for high risk severe hospitalized COVID-19 patients was a randomized, double-blind, placebo-controlled trial performed across six countries. The study evaluated the effects of 9 mg of sabizabulin administered once daily versus placebo in 210 patient cases, including cases of the Delta and Omicron variants. All patients received standard care while participating in the trial. In a prespecified planned interim analysis of 150 patients, the treatment was found to have a statistically significant 55% reduction in deaths of hospitalized severe COVID-19 patients as compared to placebo (p=0.004), which exhibited a 45% mortality rate. The Independent Data Safety Monitoring Committee recommended stopping the Phase trial earlier than anticipated due to its evidence of positive efficacy.
Veru, Inc. is seeking emergency use authorization for its drug product. The company is scaling up its production of sabizabulin in advance of FDA approval to meet market demand as soon as possible.
Currently, there are no other therapies proven to be as effective to treat hospitalized severe COVID-19 patients. Of the trial’s success, UTRF President Stacey Patterson said, “This news from Veru is very encouraging. With the rise of multiple COVID-19 variants over the last two years, it is clear there is a pressing need for more treatment options. We look forward to seeing how this therapy from Veru will positively impact the lives of patients, medical practitioners and the global population. We’re also proud to have another example of how UT researchers are translating their research efforts into life-saving products.”
“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 severe COVID-19,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients,” Dr. Steiner continued.
For more information about the results of the Phase 3 clinical study, please see the full press release from Veru, Inc.