Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss
January 08 2024 - 8:30AM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for the treatment of
obesity, oncology, and viral induced acute respiratory distress
syndrome, today announced submission of an Investigational New Drug
(IND) application with the U.S. Food and Drug Administration for
the development of enobosarm for obesity.
Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are
very effective drugs that result in significant weight loss.
Unfortunately, up to 50% of the total weight loss comes from muscle
which is problematic as muscle is necessary for metabolism,
strength, and physical function. According to the CDC, 41.5% of
older U.S. adults have obesity and could benefit from a weight loss
medication. Up to 34.4% of these patients over the age of 60 have
sarcopenic obesity which means patients are overweight or obese and
also have age-related low muscle mass. Sarcopenic obese patients
are potentially at the greatest risk for developing critically low
amounts of muscle mass when taking a GLP-1 RA medication for the
treatment of obesity. Patients with critically low muscle mass may
experience muscle weakness leading to poor balance, decreased gait
speed, mobility disability, loss of independence, falls, bone
fractures and increased mortality.
“We believe there is an urgent unmet medical need for a drug
that when given in combination with GLP-1 RA therapy prevents the
loss of muscle, while preferentially reducing fat in not only
overweight or obese patients, but especially for sarcopenic obese
or overweight elderly patients who are at-risk for developing
muscle atrophy and muscle weakness leading to frailty,” stated
Mitchell Steiner, M.D., Chairman, President, and Chief Executive
Officer of Veru Inc. “Today’s announcement is an important
milestone for Veru and ultimately for the many patients who desire
to avoid loss of muscle when taking a GLP-1 RA drug for weight
loss.”
Planned Phase 2b Enobosarm for Obesity Clinical
TrialThe Company plans to conduct a Phase 2b multicenter,
double-blind, placebo-controlled, randomized, dose-finding clinical
trial designed to evaluate the safety and efficacy of enobosarm
3mg, 6mg, or placebo as a treatment to augment fat loss and to
prevent muscle loss in approximately 90 randomized 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 of the Phase 2b clinical trial will be the change in lean
body mass (muscle) from baseline to 3 months and key secondary
endpoints will be the change from baseline to 3 months in total fat
mass, insulin resistance, total body weight, and physical function
measured by the stair climb test. The primary 3-month clinical data
from the Phase 2b clinical trial is currently expected in calendar
Q4 2024. The purpose of the Phase 2b clinical trial is to select
the optimal dose of enobosarm in combination with a GLP-1 RA that
best preserves muscle and reduces fat after 3 months of treatment
to advance into a Phase 3 obesity or overweight clinical trial.
After completing the 3-month efficacy dose-finding portion of
the Phase 2b clinical trial, participants will then continue into
an open label extension trial where all patients will receive 6 mg
of enobosarm for 3 months to determine the ability of enobosarm to
rescue or reverse muscle loss and prevent fat and weight rebound
after stopping a GLP-1 RA drug.
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 Veru’s
expectations regarding whether the FDA will accept the enobosarm
IND, whether and when the planned phase 2b trial of enobosarm
discussed above will commence, 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 meet any unmet need for obesity patients,
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 Contact:Samuel FischExecutive Director, Investor
Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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