- Obesity programs:
- Phase 2 BMT-801 clinical study with MC4R agonist
bremelanotide plus GLP-1/GIP dual agonist tirzepatide
- Topline results expected 1Q calendar year 2025
- General obesity, weight loss management, and
rare neuroendocrine and genetic diseases, including
hypothalamic obesity
- Multiple clinical trials targeted to commence 2H calendar
year 2025 with long-acting MC4R peptide and/or MC4R oral small
molecule compounds
- Dry eye disease and other ocular programs, ulcerative
colitis, and diabetic nephropathy programs:
- Program specific licensing/collaboration and spinout
discussions ongoing with multiple deals targeted for calendar year
2025
CRANBURY, N.J., Jan. 28,
2025 /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 (MCRS), today provided
an update on anticipated corporate milestones expected to occur in
calendar year 2025.
"We are poised for a transformational and defining year in 2025,
focusing on reporting the topline data of our Phase 2 BMT-801
clinical study evaluating the co-administration of bremelanotide
with tirzepatide on reducing body weight, with the readout expected
later this quarter," said Carl
Spana, Ph.D., President and Chief Executive Officer of
Palatin. "The high discontinuation rate (67%) of obese patients on
currently approved therapies resulting from side effects and a
weight-loss plateau effect in the first year, points to a need for
additional safe and effective treatments for obesity. We are
targeting to start multiple clinical trials in the second half of
calendar year 2025 with a novel and proprietary long-acting MC4R
peptide and/or an MC4R selective oral small molecule compound for
the treatment of general obesity and weight loss management, as
well as obesity associated with rare neuroendocrine and genetic
diseases."
"The central melanocortin system has a fundamental role in
regulating energy storage and feeding behaviors. MC4R is a well
validated target for treating obesity with MC4R agonists having
demonstrated in multiple clinical studies significant reductions in
caloric intake and weight loss," continued Dr. Spana. "As the
leading MCRS development company, Palatin has unique expertise,
broad intellectual property coverage and an extensive library of
compounds from which to draw to develop MC4R agonists for the
treatment of obesity. Our novel MC4R agonists could play a vital
role in treating obesity as monotherapy or in combination with
existing treatments."
Expected 2025 Milestones
Obesity Programs
- Topline results from our Phase 2 BMT-801 'signal detection'
clinical study with MC4R agonist bremelanotide plus a glucagon like
peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist
tirzepatide, expected in the first quarter of calendar year 2025.
- Primary objective: Demonstrate that co-administration
of bremelanotide with tirzepatide is safe and has a
significant effect on reducing body weight.
- General obesity, weight loss management, and
orphan/rare neuroendocrine and genetic diseases, including
hypothalamic obesity:
- Potential for monotherapy or combination (with a GLP-1
agonist) therapy.
- Investigational new drug (IND) enabling activities expected to
commence 1Q calendar year 2025.
- Filing of INDs anticipated 2H of calendar year 2025.
- Commencement of Phase 1 clinical studies targeted for 4Q
calendar year 2025.
Dry eye disease (DED) and other ocular programs, ulcerative
colitis (UC), and diabetic nephropathy programs
- Program specific licensing/collaboration and spinout activities
ongoing with multiple deals targeted for calendar year 2025.
- DED
- Concluded positive Type C meeting with the FDA and reached
agreement on sign and symptom endpoints for remaining two Phase 3
pivotal trial protocols, with patient enrollment prepared to
commence 1H calendar year 2025.
- UC
- Report topline results from our Phase 2 clinical study of
PL8177 oral formulation for the treatment of UC later this
quarter.
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 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.
