Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing innovative medicines for potentially
higher quality weight loss, oncology, and viral induced acute
respiratory distress syndrome (ARDS), today announced that the U.S.
Food and Drug Administration (FDA) has cleared the company’s
Investigational New Drug (IND) application for its Phase 2b
clinical study to evaluate enobosarm, an oral novel selective
androgen receptor modulator (SARM), to preserve muscle mass and
physical function and further increase fat loss in patients
receiving a Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
drug for potentially higher quality weight loss.
GLP-1 RA drugs are very effective drugs that result in
significant weight loss. Unfortunately, studies have shown that up
to 50% of the total weight loss comes from muscle which is
problematic as muscle is essential for metabolism, strength, and
physical function.
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
clinical study is expected to begin by 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 an open
label extension trial where all patients will receive 6 mg of
enobosarm monotherapy for 12 weeks to determine the ability of
enobosarm to rescue, or reverse muscle loss and prevent fat and
weight rebound after stopping a GLP-1 RA. The results of the
separate Phase 2b open label extension clinical study is expected
in calendar Q2 2025.
“FDA clearance of our IND will allow us to evaluate enobosarm as
a combination treatment with GLP-1 drugs to prevent the loss of
muscle, while preferentially reducing fat in not only overweight or
obese patients, but especially for the large subpopulation of
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. “We look forward to starting the
Phase 2 clinical study to further validate enobosarm’s ability to
preserve muscle and physical function while augmenting fat loss to
provide for a potentially higher quality weight loss.”
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 the development of 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.
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.
Metabolic pipeline: Enobosarm (aka ostarine, MK-2866, GTx-024,
and VERU-024), an oral daily novel selective androgen receptor
modulator (SARM), is being developed as a treatment in combination
with weight loss drugs to augment fat loss and avoid muscle loss in
overweight or obese patients for chronic weight management.
Initially, enobosarm will be developed in a Phase 2b clinical study
to address the large subpopulation of sarcopenic obese or
overweight elderly patients receiving a GLP-1 RA who are at-risk
for developing muscle atrophy and muscle weakness leading to
physical function mobility disability and frailty.
Oncology pipeline: Phase 3 clinical development of enobosarm for
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.
Infectious disease pipeline: 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 and when the planned phase 2b trial
of enobosarm discussed above will commence by April 2024, the
planned design, timing, endpoints, patient population and patient
size of such Phase 2b trial and whether such trial will
successfully meet any of its endpoints; whether enobosarm will be
shown to preserve muscle and physical function while augmenting fat
loss in the specified patient populations; whether the Phase 2b
data will be available by the end of 2024; whether the data will
warrant continued study and whether and when the clinical trial
participants will continue into an open-label extension study and
when those results will be available; whether enobosarm will meet
any unmet need for obesity patients; the planned timing, design,
endpoints, patient population and expected funding of the Company’s
breast cancer and infectious disease pipeline; 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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