- Co-Administration Phase 2 study of bremelanotide with
tirzepatide (GLP-1) to provide key information for melanocortin
treatments of obesity
- Topline data expected by end of calendar year 2024
- Additional studies under assessment for multiple metabolic
conditions
CRANBURY, N.J., June 12,
2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE
American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin receptor system, today announced the
initiation of a Phase 2 clinical study of bremelanotide for the
treatment of obesity. The clinical study will evaluate the
safety and efficacy of bremelanotide, a melanocortin 4 receptor
(MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in
obese patients. The primary endpoint of the trial is to demonstrate
the safety and increased efficacy of the co-administration of
bremelanotide with tirzepatide on reducing body weight. Topline
data results are expected by the end of calendar year 2024.
"Although GLP-1 agonists are currently the standard of care
treatment for obesity, data shows that 67% of patients discontinue
use due to side effects and a plateau effect in the first year,"
said Carl Spana, Ph.D., CEO and
President of Palatin. "We believe co-administering an MC4R agonist
with a GLP-1 agonist will achieve significant weight loss at lower
doses, with improved tolerability and quality of life for these
patients. These beliefs are supported by our published preclinical
data and multiple clinical studies demonstrating statistically
significant effects on reducing food intake and weight loss in
obese patients."
Dr. Spana added, "The MC4R pathway biology is clear and strong.
It regulates hunger, caloric intake, energy expenditure and,
consequently, body weight. Obesity has a tremendous adverse impact
on patients, their families, and across the medical community. With
significant experience and an extensive intellectual property
portfolio in the design and development of MC4R agonists, Palatin
continues to develop novel and highly selective MC4R agonists,
including oral small molecule MC4R agonists, for the potential
treatment of multiple metabolic indications, including certain rare
genetic diseases of obesity."
The clinical study, titled "BMT-801: A Phase II, Randomized,
Double-Blind, Placebo-Controlled, Clinical Study Investigating the
Safety, Tolerability, and Effectiveness of the Co-Administration of
Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of
Obesity" has Food and Drug Administration clearance. The study
is designed to enroll up to 60 patients who are actively on
tirzepatide at five trial sites in the
United States. Patients will undergo multiple assessments of
safety and efficacy to help profile the effectiveness of
bremelanotide in treating general obesity as a stand-alone
treatment or in conjunction with GLP-1/GIP therapy.
About Melanocortin 4 Receptor Agonists Effect on
Obesity
Genetic analysis has identified the melanocortin 4
receptor (MC4R) of the paraventricular nucleus of the hypothalamus
as playing a central role in appetite regulation. Genetic mutations
that inhibit signaling in the MC4R pathway lead to hyperphagia,
decreased energy expenditure and early-onset obesity; such
mutations have been identified as the cause of several rare genetic
obesity disorders. Agouti-related peptide is an endogenous
antagonist of the MC4R that works with neuropeptide Y to stimulate
appetite, whereas MC4R agonists such as α- and
β-melanocyte-stimulating hormone promote satiety. Agonism of the
MC4R therefore represents an attractive target for potential
obesity treatments.
About Obesity
Obesity, which is defined as a body mass
index (BMI) ≥30 kg/m2, represents a rising worldwide public health
concern. Obesity is associated with an increased risk of overall
mortality and serious health conditions, including high blood
pressure, high cholesterol, type 2 diabetes, coronary heart
disease, stroke and certain cancers. Health-related quality of life
is significantly lower among adults with obesity, and obesity is
associated with increased health care resource use and high
economic burden. Safe and effective obesity treatments therefore
remain a critical unmet need. The global increase in the prevalence
of obesity is a public health issue that has severe cost
implications to healthcare systems. In the United States, about 42% of adults live
with obesity, and one out of five teens between the ages of 12-19
live with obesity.
About Palatin
Palatin is a biopharmaceutical company
developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin receptor systems, with
targeted, receptor-specific product candidates for the treatment of
diseases with significant unmet medical need and commercial
potential. Palatin's strategy is to develop products and then form
marketing collaborations with industry leaders to maximize their
commercial potential. To learn more about Palatin, please visit us
on www.Palatin.com and follow us on Twitter at
@PalatinTech.
Forward-looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin Technologies, Inc., such as
statements about Palatin products in development, clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, and market potential for product candidates
are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933,
Section 21E of the Securities Exchange Act of 1934 and as that term
is defined in the Private
Securities Litigation Reform Act of 1995. Palatin
intends that such forward-looking statements be
subject to the safe harbors created thereby. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that could cause Palatin's actual results to be materially
different from its historical results or from any results expressed
or implied by such forward-looking statements. Palatin's actual
results may differ materially from those discussed in the
forward-looking statements for reasons including, but not limited
to, results of clinical trials, regulatory
actions by the FDA and other regulatory agencies and the need for
regulatory approvals, Palatin's ability to fund development of its
technology and establish and successfully complete clinical trials,
the length of time and cost required to complete clinical trials
and submit applications for regulatory approvals, products
developed by competing pharmaceutical, biopharmaceutical and
biotechnology companies, commercial acceptance of Palatin's
products, and other factors
discussed in Palatin's periodic
filings with the Securities and Exchange Commission. Palatin is not
responsible for updating events that occur after the date of this
press release.
Palatin Technologies® is a registered trademark of
Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.