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
Veru (NASDAQ:VERU)
Historical Stock Chart
From Mar 2024 to Apr 2024
Veru (NASDAQ:VERU)
Historical Stock Chart
From Apr 2023 to Apr 2024