- Positive data with Palatin's melanocortin-4 receptor (MC4R)
agonist plus glucagon like peptide-1 (GLP-1) presented at the
Peptide Therapeutics Symposium
- GLP-1 & MC4R agonist co-administration data shows
increased weight loss and greater glucose control above
monotherapy
- Preclinical data and prior clinical studies support the
further clinical development and commercial potential of Palatin's
melanocortin agonists for obesity
- Clinical study currently expected to start 1Q calendar year
2024
CRANBURY, N.J., Oct. 18,
2023 /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 plans
to initiate a clinical study of melanocortin 4 receptor (MC4R)
agonist, bremelanotide, an FDA approved product and 100% owned by
Palatin, in combination with a Glucagon Like Peptide-1 (GLP-1)
agonist, in obese patients in the first quarter of calendar year
2024. In addition, Palatin announced a poster presentation of
preclinical data, entitled Melanocortin receptor 4 agonist
PL8905 in Combination with Glucagon Like Peptide-1 Produces
Synergistic Weight Loss, Reduced Food Intake, and Greater Glucose
Control in Diet-Induced Obese (DIO) Rats (Dodd et al.) at
the Peptide Therapeutics Symposium, October
16-17, 2023 in La Jolla,
CA.
GLP-1 agonists are currently the standard of care treatment for
obesity. However, real-world use data shows that more than
two-thirds (68%) of obese patients discontinue use in the first
year. Side effects, especially at higher dose levels and a plateau
effect, contribute to the high discontinuation rate. Palatin's
innovative approach aims to address these issues by improving
treatment adherence and promoting consistent long term weight loss
through combination therapy. By co-administering an MC4R agonist
with a GLP-1 agonist, Palatin anticipates achieving significant
weight loss at lower doses, with improved tolerability. Combination
drug therapy will be a key part of improving the overall health and
quality of life for obese patients.
"With the increased use of FDA-approved GLP-1 agonists for
treating obesity there is an unmet need for treatments with
alternative mechanisms of action that will help obese patients meet
and maintain their weight loss objectives. We believe the MC4R
agonist is the best validated mechanism for adjunctive therapy with
GLP-1 agonists and weight loss maintenance," said Carl Spana, Ph.D., President and CEO of Palatin.
"With our extensive experience in obesity research, a portfolio of
novel selective MC4R agonists, and access to bremelanotide, an FDA
approved MC4R agonist, we are well positioned to advance an
MC4R agonist as a potentially
effective and safe treatment for obesity."
The Peptide Therapeutics Symposium poster presented data
evaluating the selective MCR4 agonist PL8905 from preclinical
studies in which diet-induced obese animals were treated for 5 days
with vehicle control, subcutaneous PL8905 alone and in combination
with continuous infusion of a GLP-1 agonist.
- Vehicle control and infused GLP-1 alone slightly increased body
weight.
- PL8905 monotherapy produced significant declines of 1.6% to
3.4% (P<0.01 vs vehicle).
- PL8905 combined with GLP-1, had larger declines in body weight
than monotherapy of 2.9% to
5.1% (P<0.01).
- PL8905 combined with GLP-1 also showed a significant
(P<0.01) reduction of blood glucose levels.
The use of combination therapy is supported by preclinical data
with MC4R agonist PL8905 and two previous clinical studies with
MC4R agonist bremelanotide demonstrating statistically significant
effects on reducing food intake and weight loss in obese patients
(published data; Spana C, Jordan R, Fischkoff S. Effect
of bremelanotide on body weight of obese women: Data from two
phase 1 randomized controlled trials. Diabetes Obes Metab.
2022;1-10. doi:10.1111/dom.14672 is available at
www.Palatin.com).
Palatin has extensive experience and intellectual property in
the design and development of MC4R agonists that can be used as
treatments for obesity. This includes novel selective MC4R peptide
agonists and oral small molecule MC4R
agonists.
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. For additional information regarding Palatin,
please visit Palatin's website at www.Palatin.com and follow
Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin, such as statements about results
and potential market for melanocortin receptor agonists in treating
obesity, 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 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® and Vyleesi® are
registered trademarks of Palatin Technologies, Inc.
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