- Last Patient / Last Visit Completed
- Topline Data Readout Expected Later This Quarter
CRANBURY, N.J., Feb. 6, 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, today announced the completion of its Phase 2
BMT-801 clinical study of the co-administration of MC4R
bremelanotide + GLP-1/GIP tirzepatide for the treatment of obesity.
The last patient enrolled has completed their last visit. Final
data collection and quality control will conclude shortly.
Topline data results from the Phase 2 BMT-801 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" are expected later this quarter. The study enrolled a
total of 113 patients, with 96 patients randomized. The patient
enrollment number is approximately twice the initial target of 60
patients, primarily due to strong patient demand and efficiency at
the four U.S. clinical trial sites.
"We are pleased to announce last patient/last visit in our Phase
2 obesity study and look forward to sharing the study data later
this quarter," said Carl Spana,
Ph.D., President & Chief Executive Officer of Palatin. "We
believe the data from this study will demonstrate that the
combination of MC4R + GLP-1/GIP agonists may result in additive and
synergistic effects on patient weight loss, and importantly, will
inform and support our planned clinical programs and development
programs under assessment for treating general obesity, weight loss
management, acquired and congenital hypothalamic obesity, and
potentially, rare/orphan genetically caused MC4R pathway
diseases."
"There is a clear and unmet medical need for alternative
mechanisms of action that can provide physicians and patients with
improved overall health outcomes in the pursuit of weight loss
beyond those achieved with GLP-1 and GIP drugs," continued Dr.
Spana. "The MC4R pathway plays a key role in eating behavior and
how our bodies manage energy. As a result, we believe that MC4R
agonists, especially the highly selective MC4R long-acting peptides
and oral small molecule agonists we are developing, will play an
important role for treating obesity as monotherapy and/or
combination therapy."
The primary endpoint of the Phase 2 BMT-801 clinical trial is to
demonstrate the safety and efficacy of co-administration of
bremelanotide with tirzepatide on reducing body weight. Patients
were treated with tirzepatide-only for four weeks, had eligibility
confirmed, then were randomized to one of four treatment regimens.
Patients underwent 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. MC4R agonism
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.
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, 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/palatin-completes-phase-2-obesity-study-with-mc4r-bremelanotide-plus-glp-1gip-tirzepatide-302369916.html
SOURCE Palatin Technologies, Inc.
