- Complete enrollment currently expected in 3Q 2024
- Topline results expected in 1Q calendar year 2025
- Additional studies under assessment for multiple metabolic
conditions
CRANBURY, N.J., Aug. 22,
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
patient dosing has started for the clinical study entitled:
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 (ClinicalTrials.gov Identifier: NCT06565611).
"We are excited with the start of patient dosing and by the
level of patient and physician interest in our Phase 2 clinical
study of an MCR4 agonist plus a GLP-1 to treat obese patients."
said Carl Spana, Ph.D., President
and Chief Executive Officer of Palatin. "The safe, effective, and
consistent treatment and maintenance of weight loss will require
multiple therapeutic options with differing mechanisms of action.
The MCR4 pathway plays a key role in the regulation of energy
storage and food intake, and we see MCR4 agonists playing an
important role in future combination therapies and are advancing
our novel long-acting peptide and small molecule compounds as key
possible components of such combinations."
"The growth of GLP-1 agonists to treat obesity has been
incredible and highly effective in the short run, but data shows
that 67% of patients discontinue use due to side effects and a
plateau effect in the first year. This often results in a rebound
effect with patients gaining back significant weight. Our research
coupled with 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."
The study is designed to enroll up to 60 patients at four trial
sites in the United States with
the primary endpoint of the trial 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.
Full patient enrollment in this Phase 2 clinical study of
BMT-801 is currently expected in the third quarter of calendar year
2024 with topline data readout expected in the first half of
calendar year 2025.
About Melanocortin 4 Receptor Agonists Effect on
Obesity
Genetic analysis has identified the melanocortin 4 receptor
(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 Melanocortin Receptor Agonists
The melanocortin receptor ("MCR") system has effects on
inflammation, immune system responses, metabolism, food intake, and
sexual function. There are five melanocortin receptors, MCR1
through MCR5. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other
places, for example the gut and kidney) express melanocortin
receptors, empowering our opportunity to directly activate natural
pathways to resolve disease inflammation.
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
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 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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