Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing innovative medicines for preserving
muscle for high quality weight loss, oncology, and viral induced
acute respiratory distress syndrome (ARDS), today announced the
appointment of Louis Aronne, MD, as Chief Medical Advisor and a
member of the 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) drug for
potentially higher quality weight loss.
Dr. Louis Aronne is a leading authority on obesity and its
treatment. He is the Sanford I. Weill Professor of Metabolic
Research and the director of the Comprehensive Weight Control
Center, a state-of-the-art, multidisciplinary obesity research,
education, and treatment center in the division of Endocrinology,
Diabetes & Metabolism at Weill Cornell Medicine. A graduate of
Johns Hopkins University School of Medicine, Dr. Aronne is a
founder and past chairman of the American Board of Obesity Medicine
and a past president of The Obesity Society. He is founder and
Chief Scientific Advisor of Intellihealth a cloud-based weight
management system which delivers obesity treatment online as
flyte.
He completed his internship and residency at Albert Einstein
College of Medicine and Jacobi Medical Center, followed by a Henry
J. Kaiser Family Foundation Fellowship in General Internal Medicine
at New York-Presbyterian/Weill Cornell Medical Center.
Dr. Aronne has been an investigator on more than 65 trials of
obesity treatment modalities including medications, devices, and
diets. He has authored more than 150 papers and book chapters on
obesity and edited the National Institutes of Health’s Practical
Guide to Obesity Treatment. He served as a consultant to the VA
Weight Management/Physical Activity Executive Council in the
development of the MOVE! Program, the nation’s largest medically
based weight control program. Dr. Aronne has won many awards,
including the 2015 Atkinson-Stern Award for Distinguished Public
Service and 2021 Clinician of the Year from The Obesity Society,
and several for medical teaching, including the Davidoff Prize from
Albert Einstein College of Medicine and the Elliot Hochstein Award
from Weill Cornell Medical College. Since 2001, he has appeared
annually in Castle-Connolly’s Top Doctors directory as a specialist
in obesity and internal medicine.
Dr Aronne has served as a consultant/advisor to many companies
developing treatments for obesity including Boehringer Ingelheim
Pharmaceuticals, Inc. (USA), Mediflix Inc. Pfizer, Inc., Altimmune,
Inc., Amgen, Inc., Eli Lilly and Company, Janssen Pharmaceutical
Company, Novo Nordisk Pharmaceuticals, Inc., Senda Biosciences, and
Versanis Bio.*
“The weight loss and health benefits of the new generation of
anti-obesity medications, the GLP-1 receptor agonists, are clear.
Weight loss through any modality produces muscle loss, and there is
an unmet need to minimize that in certain groups of patients in
order to produce better quality weight loss. In conjunction with a
GLP-1 drug, enobosarm has the potential to deliver better quality
weight loss while utilizing lower doses of the GLP-1 drug. This
should not only produce fewer side effects and better functioning,
but potentially lead to longer term maintenance of weight
loss.”
“We are pleased that Dr. Aronne, a world-renowned obesity
expert, will be our Chief Medical Advisor to help us develop
enobosarm as a treatment for chronic weight management,” said
Mitchell Steiner, M.D., Chairman, President, and Chief Executive
Officer of Veru Inc. “Enobosarm is a drug candidate that may
provide higher quality weight loss for obese or overweight patients
by preferentially increasing fat loss while preserving muscle. We
are fortunate that Dr. Aronne and the other senior expert members
of our Scientific Advisory Board will help guide the enobosarm
development program.”
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 daily oral 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 of both muscle and fat mass like that seen with
GLP-1 RA treatment. The totality of the clinical data from these
five clinical trials demonstrates that enobosarm treatment leads to
preservation of muscle mass with improvements in physical function
as well as significant reductions in fat mass. 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.
The efficacy and safety clinical data that were generated from
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 with higher quality total weight loss while preserving
muscle and physical function.
Planned Phase 2b enobosarm clinical trial design for
potentially high 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 preserve muscle and augment fat loss in 90
sarcopenic obese or overweight elderly (>60 years of age)
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 endpoints are total body fat mass
and physical function 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
calendar year-end 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 topline 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 ENABLAR-2 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.
*Dr. Aronne, like other members of the Company’s Scientific
Advisory Board, receives certain compensation from the Company for
his
services. 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
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