- Topline results expected in 1Q calendar year 2025
- Study is assessing the co-administration of bremelanotide
and tirzepatide on reducing body weight
- Data will inform and support the Company's obesity programs
using novel, long-acting and highly selective MC4R peptide and
small molecule compounds for treating general obesity, weight loss
management, and rare/orphan MC4R pathway diseases, including
hypothalamic obesity
CRANBURY, N.J., Oct. 31,
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 (MCR) system, today announced
it has completed enrollment in the 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."
The study enrolled approximately twice the target of 60 patients
at four US sites, primarily due to strong patient demand and
efficiency of the clinical trial sites. All patients in the study
are expected to have completed all dosing and patient visits by the
end of January 2025, with topline
data readout expected before the end of March 2025.
"We believe the study data will demonstrate that combination of
an MC4R agonist, such as bremelanotide, with a glucagon-like
peptide 1/gastric inhibitory polypeptide (GLP-1/GIP), such as
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 Chief Executive Officer of Palatin. "We believe the
data from this MC4R + GLP-1/GIP combination study will inform and
support our programs for treating general obesity, weight loss
management, and potentially, rare/orphan MC4R pathway diseases,
including hypothalamic obesity."
Dr. Spana added, "Weight loss is quick and substantial with
GLP-1/GIP therapies, but both healthcare professionals and patients
are seeking alternative treatments to these therapies due to 67% of
patients discontinuing treatment because of side effects and a
plateau effect in the first year. This often results in a rebound
effect, with patients gaining back significant weight. The MC4R
pathway plays a key role in eating behavior and how our bodies
manage energy, and we believe that MC4R agonists, especially highly
selective MC4R agonists being developed by Palatin, will play an
important role for treating obesity as monotherapy and/or
combination therapy.
The primary endpoint of the BMT-801 trial is to demonstrate the
safety and increased efficacy of co-administration of bremelanotide
with tirzepatide on reducing body weight. Patients are treated with
tirzepatide-only for four weeks, have eligibility confirmed, then
randomized to one of four treatment regimens. Patients 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.
Additional trial information can be found at
https://clinicaltrials.gov via the identifier
NCT06565611.
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 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, MC1R through MC5R. 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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SOURCE Palatin Technologies, Inc.