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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

New research hints at a few ways fatty foods affect cells in the brain, a finding that could help explain the link between a high-fat diet and impaired memory -- especially as we age. A new study in cell cultures found the omega-3 fatty acid DHA may help protect the brain from an unhealthy diet's effects by curbing fat-induced inflammation at the cellular source. New research hints at a few ways fatty foods affect cells in the brain, a finding that could help explain the link between a high-fat diet and impaired memory -- especially as we age. The Ohio State University study in cell cultures found the omega-3 fatty acid DHA may help protect the brain from an unhealthy diet's effects by curbing fat-induced inflammation at the cellular source. Separate experiments using brain tissue from aging mice showed a high-fat diet may lead specific brain cells to overdo cell-signaling management in a way that interferes with the creation of new memories. The same lab found in an earlier study in aging rats that a diet of highly processed ingredients led to a strong inflammatory response in the brain that was accompanied by behavioral signs of memory loss -- and that DHA supplementation prevented those problems. "The cool thing about this paper is that for the first time, we're really starting to tease these things apart by cell type," said senior author Ruth Barrientos, an investigator in Ohio State's Institute for Behavioral Medicine Research and associate professor of psychiatry and behavioral health and neuroscience in the College of Medicine. "Our lab and others have often looked at the whole tissue of the hippocampus to observe the brain's memory-related response to a high-fat diet. But we've been curious about which cell types are more or less affected by these saturated fatty acids, and this is our first foray into determining that." The study was published recently in the journal Frontiers in Cellular Neuroscience. For this work, the researchers focused on microglia, cells in the brain that promote inflammation, and hippocampal neurons, which are important for learning and memory. They used immortalized cells -- copies of cells taken from animal tissue that are modified to continuously divide and respond only to lab-based stimulation, meaning their behavior may not precisely match that of primary cells of the same type. Researchers exposed these model microglia and neurons to palmitic acid, the most abundant saturated fatty acid in high-fat foods like lard, shortening, meat and dairy products, to observe how it affected gene activation in the cells as well as functioning of mitochondria, structures inside cells that have a primary metabolic role of generating energy. Results showed the palmitic acid prompted gene expression changes linked to an increase in inflammation in both microglia and neurons, though microglia had a wider range of affected inflammatory genes. Pre-treatment of these cells with a dose of DHA, one of two omega-3 fatty acids in fish and other seafood and available in supplement form, had a strong protective effect against the increased inflammation in both cell types. "Previous work has shown that DHA is protective in the brain and that palmitic acid has been detrimental to brain cells, but this is the first time we've looked at how DHA can directly protect against the effects of palmitic acid in those microglia, and we see that there is a strong protective effect," said Michael Butler, first author of the study and a research scientist in Barrientos' lab. When it came to the mitochondria, however, DHA did not prevent the loss of function that followed exposure to palmitic acid. "The protective effects of DHA might, in this context, be restricted to effects on gene expression related to the pro-inflammatory response as opposed to the metabolic deficits that the saturated fat also induced," Butler said. In another set of experiments, the researchers looked at how a diet high in saturated fat influenced signaling in the brains of aged mice by observing another microglial function called synaptic pruning. Microglia monitor signal transmission among neurons and nibble away excess synaptic spines, the connection sites between axons and dendrites, to keep communication at an ideal level. Microglia were exposed to mouse brain tissue containing both pre- and post-synaptic material from animals that had been fed either a high-fat diet or regular chow for three days. The microglia ate the synapses from aged mice fed a high-fat diet at a faster rate than they ate synapses from mice fed a regular diet -- suggesting the high-fat diet is doing something to those synapses that gives the microglia a reason to eat them at a higher rate, Butler said. "When we talk about the pruning, or refinement, that needs to occur, it's like Goldilocks: It needs to be optimal -- not too much and not too little," Barrientos said. "With these microglia eating away too much too soon, it outpaces the ability for these spines to regrow and create new connections, so memories don't solidify or become stable." From here, the researchers plan to expand on findings related to synaptic pruning and mitochondria function, and to see how palmitic acid and DHA effects play out in primary brain cells from young versus aged animals. This work was supported by grants from the National Institute on Aging and the National Institute of Dental and Craniofacial Research. Additional co-authors, all from Ohio State, were Sabrina Mackey-Alfonso, Nashali Massa and Kedryn Baskin.

HONG KONG, GERMANTOWN, Md. and SUZHOU, China , June 5, 2023 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257.HK, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, today announced the interim results of an ongoing Phase I clinical trial of STP705, an siRNA (small interfering RNA) drug candidate, for fat reduction in adults undergoing abdominoplasty. The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy. This interim efficacy results examined efficacy data from six participants that were scheduled to undergo abdominoplasty. Each participant was treated with STP705 doses of 120 μg, 240 μg and 320 μg at volume per injection of either 0.5 ml or 1.0 ml per injection site as well as placebo consisting of normal saline. The test article administration area was the central to lower abdomen region designated for abdominoplasty and participants received a single injection per site up to three injections of test article approximately 28 days apart. Participants in the safety review were examined for the presence of and severity of Local Skin Reactions (LSR) including erythema, edema, and bruising over a time frame as well as the incidence (severity and causality) of any adverse events for a time frame of approximately 98 days. Secondary analysis looked at histological evidence of fat changes that would be seen in fat tissue remodeling such as fat inflammation, panniculitis, fibrosis and fat necrosis. Statistical analysis was performed with non-parametric one-way ANOVA using Kruskal-Wallis test and Dunn's multiple comparison test. The interim analysis results include data from six participants with 42 tissue samples in total. There were no significant adverse events and all tissue samples examined in this review using variables doses of STP705 showed histological evidence suggestive of fat remodeling. Based on the histological scoring and panniculitis + fat necrosis ranking, a dose-dependent effect was observed for all treatment groups comparing to the placebo group with statistical significance (P < 0.05). The 240 μg at the volume of 1.0 ml treatment group has demonstrated the most potent activity. Professor Mark Nestor, M.D., Ph.D., Director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement, Aventura, Florida, a Voluntary Professor in the Division of Plastic Surgery at the University of Miami, Miller School of Medicine and the principal investigator (PI) of the Phase I clinical study commented, "the initial data from the Phase I trial appears to indicate that the use of STP705 in the treatment of unwanted fat is safe and shows clear signs of efficacy. Safety has been examined in the first of three subjects and histology of the injected areas post abdominoplasty has been evaluated. Regarding histology, there is a clear difference in many of the specimens between the placebo, and the subjects injected with STP705. We look forward to completing this first study and analyzing all the results in the near future." "Interim data from our clinical study of STP705 for fat reduction indicate that subjects that have received various doses of STP705 show clear histologic evidence of fat changes that would be observed in fat remodeling," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "The safety results were very encouraging with no systemic adverse events and no significant local skin or tissue changes. This finding is very important when selecting a product that will be used for non-surgical fat remodeling and the fact that there was clear histological evidence of fat remodeling in a dose dependent manner is very encouraging as we move into Phase II of the program. We anticipate final study report sometime in Q3 2023 after which time, we will request a meeting with the FDA to determine the path to approval for the program." This study is the Group's first exploration to apply an RNAi therapeutic candidate for localized fat remodeling and Sirnaomics plans to use the information from this study to expand into the treatment of submental fat and other areas of noninvasive fat remodeling. The positive interim results have better informed the Group about the later stage development of STP705 in the medical aesthetics category. Together with the positive results from STP705 for treatment of squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC), the Group has successfully leveraged the proof-of-concept human data from STP705. This advancement in fat remodeling is expected to open up a new therapeutic area of medical aesthetics for Sirnaomics' pipeline and has received very positive responses from the market. "The interim results of this Phase I clinical study have brought a strong enthusiasm using RNAi drug for medical aesthetic treatment. This novel non-invasive fat-reduction option potentially offers millions of people with unwanted fat on their bodies, which are resistant to diet and exercise and influenced by aging and genetics, a unique way to address those all-too-common conditions," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "During our preclinical studies with a well-defined animal model, we found that STP705 demonstrated superior efficacy and safety, compared to a commercially available injection drug for the same indication. This observation encourages us not only to explore the utility of STP705 for medical aesthetics but also to advance it to become a best-in-class drug candidate for fat-remodeling." Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05422378. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. There are currently three product pipeline advancing programs prioritized by STP705: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC) and a Phase I for the fat remodeling. In addition, in the treatment of other indications, STP705 has received Orphan Drug Designation for the treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). About Sirnaomics Ltd. (Stock Code: 2257) Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies: Polypeptide Nanoparticle Formulation and the 2nd generation of GalNAc conjugation, the Group has established an enriched drug candidate pipeline. Sirnaomics is currently holding a leadership position on advancing RNAi therapeutics for oncology application with multiple successes of its clinical programs for STP705 and STP707. STP122G represents the first drug candidate of GalAhead™ technology entering clinical development. With the establishment of the Group's manufacturing facility, Sirnaomics currently is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . SOURCE Sirnaomics