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 the
Company will present two late-breaking abstract presentations at
the American Association of Clinical Endocrinology (AACE) 2024
Annual Meeting, taking place May 9-11, 2024 in New Orleans, LA.
The late-breaking presentations are:
Double-Blind, Multiple Ascending Dose, Safety,
Pharmacokinetic and Body Composition Study of Enobosarm in Healthy
Young and Older MenDate: Thursday May 9, 2024Start and end
time: 12:25 PM-12:40 PM Central Daylight Time
Potential to Optimize Weight Loss with Enobosarm:
Augment Reduction of Fat Mass while Preserving Muscle in Older
Patients with ObesityDate: Thursday May 9, 2024Start and
end time: 2:30 PM-2:45 PM Central Daylight Time
Additional information on the meeting can be found on the AACE
website: https://pro.aace.com/
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 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) measured by DEXA, and the key secondary
endpoints are total body fat mass and physical function measured by
stair climb test at 16 weeks. We expect to enroll our first patient
in April 2024 with topline clinical results expected by 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 gain that occurs after
stopping a GLP-1 RA drug. 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 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.
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
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, 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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