- Phase 2 clinical study expected to begin in
mid-calendar year 2024
- Topline data expected by calendar year-end 2024
- Hosting virtual KOL event "Beyond GLPs" on May 8, 2024
- Focus will be on Company's metabolic program and the
multiple roles for novel melanocortin receptor 4 agonists in
treating obesity and weight loss maintenance
CRANBURY, N.J., May 2, 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 that the U.S. Food and Drug
Administration (FDA) has completed its 30-day review of the
investigational new drug (IND) application for the use of
bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the
treatment of obesity. The Company is cleared to begin enrollment in
a Phase 2 clinical study evaluating the safety and efficacy of
bremelanotide, co-administered with tirzepatide (GLP1/GIP) in obese
patients. The Phase 2 clinical study is expected to start
mid-calendar year 2024, with topline data results by the end of
calendar year 2024.
Phase 2 Trial Design
The clinical study, "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 been reviewed by FDA with an
approval to proceed under Palatin's IND. The study is designed to
enroll up to 60 patients actively on tirzepatide at approximately
five trial sites in the U.S. The primary endpoint of the trial is
to demonstrate the safety and increased efficacy of
co-administration of bremelanotide with tirzepatide on reducing
body weight. Patients will be treated with tirzepatide-only for
four weeks, have eligibility confirmed, then randomized to one of
four treatment regimens. 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.
"Therapeutic options for obesity treatment requires multiple
pathways to safely, effectively, and consistently treat and
maintain weight loss. MCR4 agonism is a well validated mechanism
for weight loss. Our research and emerging clinical data indicate
that combining an MCR4 agonist with incretin therapeutics like
tirzepatide may result in synergistic effects on weight loss
allowing for increased weight loss at lower and better tolerated
doses," said Carl Spana, Ph.D.,
President and CEO of Palatin. "We have extensive experience in
obesity research, a portfolio of novel selective MCR4 agonists, and
ready access to bremelanotide, an FDA approved MCR4 agonist. We are
excited by the FDA's acceptance of our IND to further study the
utility of melanocortin agonists as a potential treatment option
for obesity."
Virtual KOL Event
The event will focus on the
Company's metabolic program evaluating novel selective melanocortin
receptor 4 agonists (MCR4) as effective and safe treatment for
obesity and weight loss maintenance. The KOL event features
Jesse Richards, DO (Oklahoma State University College of Osteopathic
Medicine), who will discuss the current treatment landscape for
obesity, including the use of incretin therapeutics as the standard
of care, and the unmet need for new treatments with alternative
mechanisms of action, and how combining a melanocortin agonist with
incretins, like GLP-1s, can optimize treatment.
The virtual KOL event will take place at 10:00 AM Eastern Time on May 8th. A live question and answer
session will follow the formal presentations. To register for the
event, please click here.
Palatin has significant experience and an extensive intellectual
property portfolio in the design and development of MCR4 agonists
that can be used as treatments for obesity. This includes novel
selective MCR4 peptide agonists and oral small molecule MCR4
agonists.
Palatin previously 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 MCR4 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.
The use of combination therapy is supported by preclinical data
with MCR4 agonist PL8905 and two previous clinical studies with
MCR4 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).
About Melanocortin Receptor 4 Agonists Effect on
Obesity
Genetic analysis has identified the melanocortin
receptor 4 (MCR4) of the paraventricular nucleus of the
hypothalamus as playing a central role in appetite regulation.
Genetic mutations that inhibit signaling in the MCR4 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 MCR4 that works with neuropeptide Y
to stimulate appetite, whereas MCR4 agonists such as α- and
β-melanocyte-stimulating hormone promote satiety. Agonism of the
MCR4 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.