Palatin Announces FDA Clearance of IND Application for Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity

• Phase 2 The clinical study is expected to begin in mid-2024

• Organization of KOL virtual event “Beyond GLPs”. May 8, 2024

CRANBURY, NJ, 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 US Food and Drug Administration (FDA) has completed their 30-day investigational drug application (IND) review for the use of bremelanotide, a melanocortin receptor 4 (MCR4) agonist, for the treatment of obesity. The company has authorization 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 begin in mid-calendar year 2024, with primary 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 Efficacy of Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity” has been reviewed by the 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 US. The primary endpoint of trial is to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide to reduce body weight Patients will be treated with tirzepatide alone for four weeks, eligibility has been confirmed and then , will be subjected to one of four treatment regimens the efficacy of bremelanotide in the treatment of general obesity as a stand-alone treatment or in combination with GLP-1/GIP therapy.

“Therapeutic options for the treatment of obesity require 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 such as tirzepatide may result in synergistic effects on weight loss that allow for increased weight loss at lower, better-tolerated doses,” he said. Carl Spain, 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 about the FDA’s acceptance of our IND to study plus the utility of melanocortin agonists as a potential treatment option for obesity.”

The story continues

KOL Virtual Event
The event will focus on the company’s metabolic program evaluating novel selective melanocortin receptor 4 (MCR4) agonists as an effective and safe treatment for obesity maintenance and weight loss. Features of the KOL event Jesse RichardsDO (Oklahoma State University College of Osteopathic Medicine), who will discuss the current landscape of obesity treatment, 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 to combine a melanocortin agonist with incretins, such as GLP-1, can optimize treatment.

The virtual KOL event will take place at 10:00 AM Eastern Time activated May 8^th. A live question and answer session will follow the formal presentations. To register for the event, click here.

Palatin has extensive 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 MCR4-selective peptide agonists and oral MCR4 small molecule agonists.

Palatin previously announced a poster presentation of preclinical data, titled The melanocortin 4 receptor agonist PL8905 in combination with glucagon-like peptide-1 produces synergistic weight loss, reduced food intake, and enhanced 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 for obesity. However, real-world usage data shows that more than two-thirds (68%) of obese patients stop using it within the first year. Side effects, especially at higher doses 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 expects to achieve 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 of obese patients.

The use of combination therapy is supported by preclinical data with the MCR4 agonist PL8905 and two previous clinical studies with the MCR4 agonist bremelanotide demonstrating statistically significant effects on reducing food intake and weight loss in patients obese (published data; Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight in obese women: data from two phase 1 randomized controlled trials 2022; 1-10: doi:10.1111/dom.14672 .

On the effect of melanocortin 4 receptor agonists on obesity
Genetic analysis has identified melanocortin receptor 4 (MCR4) in the paraventricular nucleus of the hypothalamus as having 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; these mutations have been identified as the cause of several rare genetic disorders of obesity. Agouti-related peptide is an endogenous MCR4 antagonist that works with neuropeptide Y to stimulate appetite, while MCR4 agonists such as melanocyte-stimulating hormone – and – promote satiety. MCR4 agonism therefore represents an attractive target for potential obesity treatments.

About obesity
Obesity, which is defined as a body mass index (BMI) of 30 kg/m2, represents a growing public health concern worldwide. Obesity is associated with an increased risk of overall mortality and serious health problems, 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 use of health care resources and high economic burden. Therefore, safe and effective obesity treatments remain a critical unmet need. The global increase in the prevalence of obesity is a public health problem that has serious cost implications for healthcare systems. In the united statesaround 42% of adults live with obesity, and one in five teenagers between the ages of 12 and 19 lives with obesity.

About Palatine
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of melanocortin receptor systems, with receptor-specific product candidates for the treatment of diseases with significant medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing partnerships with industry leaders to maximize their commercial potential. To learn more about Palatin, visit us at 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 Palatin Technologies, Inc.’s future expectations, 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 the 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 such term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends these forward-looking statements to be subject to the safe harbors created thereby. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to differ materially from its historical results or from any results expressed or implied by these 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, the results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatine’s ability to finance development. of its technology and to successfully establish and complete clinical trials, the 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 Palatine products and other factors discussed. in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events occurring after the date of this press release.

Palatinate Technologies ^{is a registered trademark of Palatin Technologies, Inc.}

View original content to download media: https://www.prnewswire.com/news-releases/palatin-announces-fda-clearance-of-ind-application-for-the-co-administration-of-bremelanotide-with-tirzepatide -glp-1-for-the-treatment-of-obesity-302134204.html

SOURCE Palatin Technologies, Inc.