MIAMI, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced the formation of a new Scientific Advisory Board to support the advancement of enobosarm, an oral novel selective androgen receptor modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs for potentially higher quality weight loss. The Scientific Advisory Board brings deep and complementary knowledge in metabolic diseases, obesity, weight management, muscle preservation and physical function in addition to significant experience in clinical research and in drug development. “We are pleased to announce the addition of such an esteemed group of experts to our new Scientific Advisory Board,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “All of these experts in obesity and muscle share our vision and goal to develop enobosarm as a drug candidate that may potentially enhance quality weight loss for obese or overweight patients by preferentially increasing fat loss while preserving muscle. We know that all of them will make valuable contributions to guide the enobosarm development program.” The members of Veru’s new Scientific Advisory Board are: Dr. Caroline M. ApovianCaroline M. Apovian, MD, FACP, FTOS, DABOM is Co-Director of the Center for Weight Management and Wellness (CWMW) in the Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. For over thirty years, Dr. Apovian has held a position at the forefront of the obesity and nutrition fields. One of the world’s premier weight management experts, she has distinguished herself as a leading researcher, healthcare provider, teacher, and New York Times bestselling author. In collaboration with the Divisions of Gastroenterology and Metabolic Surgery, the CWMW will offer comprehensive, multidisciplinary care for patients seeking weight loss. Under Dr. Apovian’s direction, the Endocrinology arm of the Center will specialize in the assessment and treatment of obesity and its comorbidities. Nationally, she is one of the founding creators of the American Board of Obesity Medicine which provides certification and recognition for physicians who have specialized knowledge and training in the practice of obesity medicine. Her current research interests are weight change and its effects on adipose tissue metabolism and inflammation, obesity and cardiovascular disease, resolution of type 2 diabetes and cardiovascular disease in the bariatric surgery population, disparities in the treatment of obesity in underserved populations, and novel pharmacotherapeutic agents for the treatment of obesity. She is also an expert in sampling subcutaneous adipose tissue and muscle tissue in humans and has been studying the relationship between adipose tissue inflammation and obesity for over 15 years. Dr. Apovian has published over ten books and over 200 peer-reviewed original research and review articles on obesity and nutrition. Dr. Apovian was a member of the expert panel for updating the 2013 AHA/ACC/TOS Clinical Guidelines for the Management of Overweight and Obesity in Adults, published in the Circulation and Obesity journals and was the Chair of the Endocrine Society Guidelines for Medical Treatment of Obesity published in the Journal of Endocrinology and Metabolism in 2015. She is a former Nutrition Consultant for the National Aeronautics and Space Administration (NASA). Dr. Apovian has given over 200 invited lectures nationally and internationally and served as President of The Obesity Society in 2017-2018. She is also a past Co-Director for the NIH-funded Boston Nutrition and Obesity Research Center. Dr. Shalender BhasinShalender Bhasin, M.D., B.S., is a Professor of Medicine at the Harvard Medical School, and Director of the Research Program for Men’s Health and Aging at the Brigham and Women’s Hospital in Boston, Mass. He is the co-Director of the Brigham Center for Transgender Health. He is also the Director of the Boston Claude D. Pepper Aging Research Center at the Harvard Medical School. Dr. Bhasin is one of the foremost experts in men’s health and aging. He has published more than 400 original research papers in top tier journals and has conducted some of the most important randomized trials of testosterone in men and women. His lab has characterized the mechanisms of testosterone's action and the role of steroid 5-alpha reductase in adults. He led the Endocrine Society's expert panel that developed the guidelines for testosterone treatment of hypogonadal men since 2005. His lab has investigated the mechanisms of muscle loss with aging. He chaired an expert panel that developed the evidence-based definition of sarcopenia and has conducted many randomized trials of function promoting therapies. He has been investigating the role of Nicotinamide Adenine Dinucleotide (NAD) in aging biology and the potential applications of NAD augmentation to treat age-related diseases. Dr. Bhasin has been the recipient of numerous research, teaching, and mentorship awards throughout his career. He received the Endocrine Society's Outstanding Clinical Investigator Award, and the American College of Endocrinology's Frontiers in Science Award. Shalender Bhasin is the recipient of research grants from AbbVie, MIB and FPT. He is also a consultant with Novartis. Dr. Adrian DobsAdrian Sandra Dobs, MD, MHS, is Professor of Medicine and Oncology and Director of the Johns Hopkins Clinical Research Network of the Johns Hopkins Institute for Clinical and Translational Research (JHCRN). The JHCRN is a multi-institutional collaboration linking academic and community hospitals in the mid-Atlantic United States. Dr Dobs received her undergraduate degree from Cornell University, a medical degree from Albany Medical College, in New York, and completed an internship in internal medicine at Montefiore Hospital, Albert Einstein College of Medicine, in the Bronx, New York. She held a fellowship in endocrinology from Johns Hopkins University School of Medicine and earned a master’s in health sciences degree in cardiovascular epidemiology at the Johns Hopkins University Bloomberg School of Public Health. Dr Dobs is an active clinician seeing patients with general endocrine problems, with a subspecialty in sex hormone disorders. She has been an investigator on several NIH-funded studies evaluating the relationship of sex hormones and cardiovascular risk. She lectures in the United States and internationally in these areas, as well as aging and testosterone therapy and testosterone and cardiovascular disease. With book chapters, monographs, and journal articles, as well as television and Web contributions, Dr Dobs has published extensively on topics that include sex hormones and its relationship to metabolic disorders. Journals publishing her research include the New England Journal of Medicine, Journal of Clinical Endocrinology and Metabolism, JAIDS, and Journal of Andrology. She has sat on multiple NIH grant review committees and data safety monitoring boards. Dr Dobs is very active in mentoring medical students and postdoctoral fellows and was honored by the Johns Hopkins University School of Medicine with the David M. Levine Excellence in Mentoring Award. Dr. William J. EvansWilliam J. Evans, PhD is an Adjunct Professor of Medicine in the Division of Geriatrics at the Duke University Medical Center and Human Nutrition in the Department of Nutritional Sciences at the University of California, Berkeley. He previously was Vice President and head of the Muscle Metabolism Discovery Unit at GSK. He has served as laboratory director at the Reynolds Institute on Aging at the University of Arkansas for Medical Sciences, the Noll Physiological Research Center at Penn State and as the Chief of the Human Physiology Laboratory at the Human Nutrition Research Center on Aging at Tufts University. With an H-index of 124 and more than 78,000 citations he is the author or co-author of more than 350 publications in scientific journals and was the first to describe sarcopenia. He is the co-inventor of the D3Creatine dilution method, a non-invasive and accurate measurement of muscle mass which is strongly related to health outcomes in older people. His work has been featured in the PBS series, NOVA, Good Morning America, 20/20, CBS evening news, CNN, and the New York Times. Dr. Evans has been invited to testify before the US Senate Select Committee on Aging on strategies to save Medicare. He is a founding member of the Society for Sarcopenia, Cachexia, and Wasting Disorders and recently received the Lifetime Achievement Award from the International Conference on Frailty and Sarcopenia Research. About Sarcopenic Obesity According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate frailty in older obese or overweight elderly patients. About Enobosarm Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while avoiding muscle loss.In addition, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women dosed with duration of treatment in some patients for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone. Planned Phase 2b enobosarm clinical trial design for potentially higher quality weight loss The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 90 sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint is lean body mass (muscle), and the key secondary endpoint is total body fat mass at 16 weeks. The IND has received FDA clearance, and the clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024. After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight rebound that occurs after stopping a GLP-1 RA drug. The results of the separate Phase 2b extension clinical study is expected in calendar Q2 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources. The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the planned phase 2b trial of enobosarm discussed above will commence or produce topline data or patients will progress into the extension study, the planned design, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Scientific Advisory Board will make valuable contributions to the Company’s metabolic development program, and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of Veru Inc. (the Company) and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the Company’s expectations regarding the completion, timing and size of the proposed public offering and the use of proceeds therefrom. This list is not exhaustive and other risks are detailed in the Company’s periodic reports filed with the SEC, including the Company's Form 10-K for the year ended September 30, 2023. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com
