UTRF licensee Veru Inc. to seek emergency use authorization for sabizabulin
University of Tennessee (UT) Research Foundation licensee Veru Inc. has announced that the company’s Phase 3 clinical trial of sabizabulin as an oral therapy for hospitalized patients who are at a high risk for Acute Respiratory Distress Syndrome (ARDS) and death due to severe COVID-19 showed the drug to be safe and effective.
In fact, the trial was halted early due to the positive efficacy results, and the company announced that it will seek emergency use authorization from the U.S. Food and Drug Administration (FDA) to bring the drug product to market. As it awaits approval, Veru Inc. is scaling up its production of sabizabulin in advance to meet market demand as soon as possible.There were a number of key contributors to the drug’s development from the UT Health Science Center, starting with Wei Li, Distinguished Professor in the Department of Pharmaceutical Sciences and Director of the UTHSC College of Pharmacy Drug Discovery Center; and Duane D. Miller, Professor Emeritus in the Department of Pharmaceutical Sciences. Both were involved in the initial design and testing of sabizabulin, working in collaboration with scientists at The Ohio State University and GTx Inc. Initial in vitro testing of sabizabulin for this antiviral use was conducted at the UTHSC Regional Biocontainment Lab (RBL) by Colleen Jonsson, Professor and Van Vleet Chair of Excellence in Virology who is also RBL Director. Demonstration that sabizabulin had anti-inflammatory activity was performed in a septic shock mouse model by the laboratory of the late Arnold Postlethwaite, 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. 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, Chairman, President and Chief Executive Officer of Veru Inc. “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.”