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 that it has
enrolled the first patients in its Phase 2b clinical trial of
enobosarm, an oral selective androgen receptor modulator (SARM), to
avoid muscle loss and to augment fat loss when combined with
semaglutide (Wegovy®), a Glucagon-like peptide-1 receptor agonist
(GLP-1 RA) drug, for potentially higher quality weight loss.
Topline clinical data is expected in the fourth quarter of the
calendar year 2024.
"We are excited to enroll the first patients in the Phase 2b
clinical trial, marking an important milestone in the development
of enobosarm for high quality weight loss,” said Mitchell Steiner,
M.D., Chairman, President, and Chief Executive Officer of Veru Inc.
“There is a significant unmet medical need to have a drug that may
effectively preserve muscle in patients undergoing weight loss
therapy with GLP-1 drugs. Patients receiving GLP-1 drugs lose
significant muscle as part of the weight loss which can lead to
muscle weakness in older patients with both obesity and low muscle
reserves. Muscle weakness is associated with mobility disability
and loss of balance resulting in a higher risk for falls and hip
and pelvic fractures. In fact, the package insert for Wegovy® has
been updated based on the recently reported SELECT (Semaglutide
Effects on Heart Disease and Stroke in Patients with Overweight or
Obesity) cardiovascular outcomes clinical trial to highlight the
four-fold increase in pelvic and hip fractures that was observed in
patients greater than 75 years of age receiving Wegovy® compared to
placebo.”
“While there is clear medical benefit from weight loss with
semaglutide, improving weight loss quality by minimizing the loss
of lean mass is the next step forward in improving metabolic
complications of obesity. This Phase 2b clinical trial of enobosarm
will provide important insights into how this goal can be
achieved,” said Louis Aronne, MD, obesity medicine specialist at
Weill Cornell Medicine in New York, Chief Medical Advisor to
Veru*.
About the Enobosarm Phase 2b clinical trialThe
Phase 2b, multicenter, double-blind, placebo-controlled,
randomized, dose-finding clinical trial was 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 measured by DEXA, and the key secondary endpoints are
differences in total body fat mass measured by DEXA and physical
function as measured by stair climb test at 16 weeks. Topline
clinical results from the trial are expected by the end 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 gain that occurs after discontinuing
a GLP-1 RA. The topline results of the separate 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. 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.
*Dr. Aronne, like certain other members of the Company’s
Scientific Advisory Board, receives 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 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 or provide important insights into quality
weight loss therapy, 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 risks that 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, as amended by the Form
10-K/A.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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