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

• Phase 2 clinical study expected to begin in mid-calendar year 2024
  • Topline data expected by calendar year-end 2024
• Hosting virtual KOL event "Beyond GLPs" on May 8, 2024
  • Focus will be on Company's metabolic program and the multiple roles for novel melanocortin receptor 4 agonists in treating obesity and weight loss maintenance

CRANBURY, N.J., 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 U.S. Food and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the treatment of obesity. The Company is cleared 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 start mid-calendar year 2024, with topline 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 Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity" has been reviewed by 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 U.S. The primary endpoint of the trial is 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.

"Therapeutic options for obesity treatment requires 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 like 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 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 by the FDA's acceptance of our IND to further study the utility of melanocortin agonists as a potential treatment option for obesity."

Virtual KOL Event
The event will focus on the Company's metabolic program evaluating novel selective melanocortin receptor 4 agonists (MCR4) as effective and safe treatment for obesity and weight loss maintenance. The KOL event features Jesse Richards, DO (Oklahoma State University College of Osteopathic Medicine), who will discuss the current treatment landscape for obesity, 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 combining a melanocortin agonist with incretins, like GLP-1s, can optimize treatment.

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

Palatin has significant 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 selective MCR4 peptide agonists and oral small molecule MCR4 agonists.

Palatin previously announced a poster presentation of preclinical data, entitled Melanocortin receptor 4 agonist PL8905 in Combination with Glucagon Like Peptide-1 Produces Synergistic Weight Loss, Reduced Food Intake, and Greater 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 treatment for obesity. However, real-world use data shows that more than two-thirds (68%) of obese patients discontinue use in the first year. Side effects, especially at higher dose levels 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 anticipates achieving 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 for obese patients.

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

About Melanocortin Receptor 4 Agonists Effect on Obesity
Genetic analysis has identified the melanocortin receptor 4 (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 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. To learn more about Palatin, please visit us on 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 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 agencies 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.

SOURCE Palatin Technologies, Inc.