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, today announced Steven B.
Heymsfield, M.D., a Professor and the Director of the Body
Composition-Metabolism Laboratory at the Pennington Biomedical
Research Center in Baton Rouge, Louisiana, as the Principal
Investigator for the Company’s Phase 2b clinical trial of enobosarm
to preserve muscle while augmenting fat loss in patients receiving
a GLP-1 RA for weight loss.
Dr. Heymsfield is a leading authority on body composition
assessment and his research focuses primarily on human obesity,
including energy balance regulation, weight loss treatments,
co-morbidity effects, and development of related mathematical
models. He has a long term-interest in the development of methods
for evaluating body composition and the application of new
technologies to the study of human metabolism.
Dr. Heymsfield received a degree in medicine from Mount Sinai
School of Medicine, and he completed his internship, residency, and
fellowship in pharmacology at Emory University. He then joined the
Emory University School of Medicine faculty, holding positions
there including Associate Professor of Medicine and Assistant
Director of the NIH-funded Clinical Research Unit. Expanding on his
interests in obesity and metabolism, Dr. Heymsfield next moved to
Columbia University, College of Physicians and Surgeons and there
he held positions as Professor of Medicine and Deputy Director, New
York Obesity Research Center at St. Luke’s-Roosevelt Hospital. He
and his Columbia colleagues conducted wide ranging clinical studies
on obesity with a focus on energy metabolism, body composition, and
pharmacologic weight control management. Prior to his Pennington
Biomedical position, Dr. Heymsfield worked with Merck & Co. for
5 years, initially as Executive Director in the Obesity Group and
then as Global Director of Scientific Affairs.
Dr. Heymsfield has published more than 600 peer-reviewed papers
covering topics such as obesity, malnutrition, cachexia, body
composition, and caloric expenditure. His contributions to the
study of human nutrition led to the TOPS Award from The Obesity
Society, the Rhoads Award from the American Society of Parenteral
and Enteral Nutrition (ASPEN), the Robert H. Herman Memorial Award,
American Society of Nutrition (ASN), the George Bray Founders Award
from The Obesity Society, and he was honored for his role in the
FDA ban on ephedra, receiving the 2004 NYC Mayor’s Award for
Science and Technology. Dr. Heymsfield was elected Fellow of The
Obesity Society in 2014, and he is an honorary member of the
American Dietetic and Chilean Clinical Nutrition Associations. Dr.
Heymsfield is past president of ASPEN and ASN and he is
vice-president of The Obesity Society.
As the Principal Investigator for the Company’s enobosarm Phase
2b clinical trial, Dr. Heymsfield will lead the clinical trial
sites. He will also participate in the study analysis and
contribute to reporting the results to the FDA and scientific
journals and meetings.
“I am pleased to serve as the Principal Investigator for this
important Phase 2b enobosarm clinical trial. I am enthusiastic to
be participating in enobosarm’s development, a medicine that has a
novel established mechanism of action that has the potential to
improve the quality of weight loss for these patients,” said Steven
Heymsfield, MD, a Professor and the Director of the Body
Composition-Metabolism Laboratory at the Pennington Biomedical
Research Center in Baton Rouge, Louisiana.
"Dr. Heymsfield is an expert in body composition and obesity and
an ideal clinical leader to serve as the Principal Investigator of
the enobosarm Phase 2b clinical trial," said Mitchell Steiner,
M.D., Chairman, President, and Chief Executive Officer of Veru Inc.
“Veru is proud to have Dr. Heymsfield as our partner with the
enobosarm clinical trial. There is a significant unmet medical need
for patients undergoing weight loss treatments with GLP-1 RAs to
address the issue of muscle loss. We believe enobosarm could
potentially be a great addition for patients to make their weight
loss journey as healthy as possible. We look forward to enrolling
this Phase 2b clinical trial expeditiously with data expected by
year-end."
About the Enobosarm Phase 2b clinical trialThe
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
approximately 90 patients with sarcopenic obesity or overweight
elderly (>60 years of age) patients receiving semaglutide
(Wegovy®). The primary endpoint is difference in total lean body
mass, and the key secondary endpoints are differences in total body
fat mass and physical function as measured by stair climb test at
16 weeks. The Phase 2b clinical trial is actively enrolling
patients from up to 15 clinical sites in the United States. Topline
clinical results from the trial are expected by the end of calendar
year 2024.
After completing the efficacy dose-finding portion of the Phase
2b clinical trial, it is expected that participants will then
continue in blinded fashion 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 gain that occurs after discontinuing a GLP-1 RA. The
topline results of the separate blinded Phase 2b extension clinical
study are expected in calendar Q2 2025.
About Sarcopenic ObesityAccording 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 the development of frailty in older obese or overweight
elderly patients.
About EnobosarmEnobosarm (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 which is similar to what is
observed with in patients taking GLP-1 RA drugs. We believe the
totality of the clinical data from these previous 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 preserving muscle mass.
Importantly, enobosarm has a large safety database, which
includes 27 clinical trials involving 1581 men and women, some of
which included patients dosed for up to 3 years. In this large
safety database, enobosarm was generally well tolerated with no
increases in gastrointestinal side effects. This is important as
there are already significant and frequent gastrointestinal side
effects with a GLP-1 RA treatment alone.
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 and
abemaciclib 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 phase 2b trial of enobosarm discussed above
will produce topline data or patients will progress into the
extension study, the planned design, number of sites, 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 Company’s scientific advisors will
make valuable contributions to the Company’s enobosarm 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 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: the
development of the Company’s product portfolio and the results of
clinical studies possibly being unsuccessful or insufficient to
meet applicable regulatory standards or warrant continued
development; the ability to enroll sufficient numbers of subjects
in clinical studies and the ability to enroll subjects in
accordance with planned schedules; the ability to fund planned
clinical development as well as other operations of the Company;
the timing of any submission to the FDA or any other regulatory
authority and any determinations made by the FDA or any other
regulatory authority; the Company’s existing product, FC2, and any
future products, if approved, possibly not being commercially
successful; the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations; demand for, market acceptance of, and competition
against any of the Company’s products or product candidates; new or
existing competitors with greater resources and capabilities and
new competitive product approvals and/or introductions; changes in
regulatory practices or policies or government-driven healthcare
reform efforts, including pricing pressures and insurance coverage
and reimbursement changes; risks relating to the Company's
development of its own dedicated direct to patient telehealth
platform, including the Company's lack of experience in developing
such a platform, potential regulatory complexity, development
costs, and market awareness and acceptance of any telehealth
platform we develop; risks relating to our ability to increase
sales of FC2 after significant declines in recent periods due to
telehealth industry consolidation and the bankruptcy of a large
telehealth customer; the Company’s ability to protect and enforce
its intellectual property; the potential that delays in orders or
shipments under government tenders or the Company’s U.S.
prescription business could cause significant quarter-to-quarter
variations in the Company’s operating results and adversely affect
its net revenues and gross profit; the Company’s reliance on its
international partners and on the level of spending by country
governments, global donors and other public health organizations in
the global public sector; the concentration of accounts receivable
with our largest customers and the collection of those receivables;
the Company’s production capacity, efficiency and supply
constraints and interruptions, including potential disruption of
production at the Company’s and third party manufacturing
facilities and/or of the Company’s ability to timely supply product
due to labor unrest or strikes, labor shortages, raw material
shortages, physical damage to the Company’s and third party
facilities, product testing, transportation delays or regulatory
actions; costs and other effects of litigation, including product
liability claims and securities litigation; the Company’s ability
to identify, successfully negotiate and complete suitable
acquisitions or other strategic initiatives; the Company’s ability
to successfully integrate acquired businesses, technologies or
products; and other risks detailed from time to time in the
Company’s press releases, shareholder communications and Securities
and Exchange Commission filings, including the Company's Form 10-K
for the year ended September 30, 2023, as amended by the Form
10-K/A, and subsequent quarterly reports on Form 10-Q. These
documents are available on the “SEC Filings” section of our website
at www.verupharma.com/investors.
* Wegovy® is a registered trademark of Novo Nordisk A/S
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Veru (NASDAQ:VERU)
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Veru (NASDAQ:VERU)
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