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MIAMI, FL, June 01, 2023 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced the appointment of Erik Swenson, M.D., a world-renowned pulmonologist specializing in critical care, and Robert Schooley, M.D., an accomplished infectious disease physician and researcher, to its Infectious Disease Scientific Advisory Board (SAB) to join David D. Ho, M.D., a trailblazer of infectious disease viral research and therapeutic development, who is Chairman of the SAB.
“We are pleased to share that Dr. Erik Swenson and Dr. Robert Schooley are joining our Scientific Advisory Board focused on infectious diseases,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Our Company’s strategy to progress sabizabulin for serious and life-threatening infectious diseases like viral induced ARDS is consistent with both doctors’ pertinent and extensive experiences and professional aims. We are fortunate to receive their scientific guidance and support, alongside Dr. David Ho’s, to continue advancing sabizabulin, an important, potentially lifesaving drug candidate.”
Erik Swenson, M.D. is a pulmonologist affiliated with Veterans Affairs Puget Sound Health Care System-Seattle. Dr. Swenson specializes in critical care medicine, internal medicine and pulmonology, with particular concentration in adult acute respiratory distress syndrome (ARDS), pulmonary hypertension, chronic obstructive pulmonary disease, asthma, and tuberculosis for over four decades. Additionally, he is a Professor of Medicine, Physiology and Biophysics at the University of Washington and previously served as the Chairman of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee for 10 years. Dr. Swenson received his M.D. from University of California San Diego School of Medicine.
“I am grateful for the opportunity to work closely with Veru’s experienced scientists and executives who are working diligently to deliver a novel medicine with antiviral and anti-inflammatory properties to patients suffering from viral induced ARDS,” said Erik Swenson, M.D.
Robert Schooley, M.D., an infectious disease specialist, is affiliated with UC San Diego Health-La Jolla and Hillcrest, where he serves as a Professor in the Division of Infectious Diseases at UC San Diego School of Medicine. His primary research interests include influenza, global health and international medicine, and the diagnosis and management of infections that cause death and morbidity in resource-limited settings. Notably, Dr. Schooley played a key role as one of the first researchers to describe the humoral and cellular immune responses to HIV infection. He received his M.D. from Johns Hopkins University School of Medicine.
“The clinical data Veru has generated in COVID-19 induced ARDS and more recently preclinically in smallpox and influenza, additional viral ARDS-related diseases, indicate the Company is poised to potentially provide a therapeutic solution to patients worldwide. I am excited to serve as a member of its Scientific Advisory Board during this major inflection point,” said Robert Schooley, M.D.
Drs. Swenson and Schooley join David D. Ho, M.D., Chairman of Veru’s SAB. David D. Ho, M.D. is the Founding Scientific Director of the Aaron Diamond AIDS Research Center and the Clyde and Helen Wu Professor of Medicine at Columbia University Irving Medical Center, a Member of The National Academy of Medicine, Member of The American Academy of Arts & Sciences, and a Fellow of The American Association for the Advancement of Science. He received his M.D. from Harvard Medical School and has received fourteen honorary doctorates over the course of his career. In his noteworthy research, Dr. Ho discovered the nature of HIV replication, and the resulting innovative combination therapy remarkably enabled patients to manage this disease. In 1996, Dr. Ho was selected by TIME Magazine as man of the year as a doctor who gives hope to millions in the daunting fight against HIV. In addition, Dr. Ho is leading a multi-disciplinary team of physicians, and scientists to advance the development of new drugs that target SARS-CoV-2 mutants.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases.
Oncology program focuses on breast cancer
The Company’s late stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.
- Enrolling Phase 2b/3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib).
- Planned Phase 2b/3 study of enobosarm in nonmeasurable bone only metastatic breast cancer.
Infectious disease program focuses on viruses that pose serious worldwide global threat
- COVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. In April 2023, the Company reached agreement with FDA on design of Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. The Company plans to initiate this Phase 3 clinical study in 2H 2023.
- Smallpox and Ebola viruses: The Company is planning a pre-IND meeting with FDA to discuss the development of sabizabulin for smallpox virus and Ebola virus under the Animal Rule FDA regulatory approval pathway.
- Influenza: The Company is planning a Phase 3 clinical trial to evaluate sabizabulin in hospitalized influenza patients at high risk for ARDS.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is comprised of:
- FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.