Palatin Announces FDA Review of IND Application for Combined Administration of Bremelanotide and Tirzepatide (GLP-1) for the Treatment of Obesity.

• Phase 2 doctoral studies expected to begin in mid-calendar 2024

• Running the KOL event “Beyond GLPs” at May 8, 2024

CRANBURY, NJ, May 2, 2024 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company that develops first-in-class drugs based on molecules that modulate the activity of the melanocortin receptor system, today announced that the US Food and Drug Administration. FDA) has completed its 30-day review of an investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the treatment of obesity. The company is set 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. A Phase 2 clinical study is expected to begin in mid-calendar 2024, with primary data results by the end of calendar 2024.

Phase 2 Experimental Design
A clinical study, “A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Efficacy of the Combination of Bremelanotide and Tirzepatide (GLP-1/GIP) for the Treatment of Obesity.“It has been reviewed by the FDA with approval to proceed under Palatin’s IND. The study is designed to actively enroll 60 patients to tirzepatide at approximately five trial sites in the United States. The primary endpoint of the trial is to demonstrate safety and efficacy additional. of the joint administration of bremelanotide and tirzepatide in weight reduction. The four treatments will undergo multiple safety and efficacy trials to help profile the effectiveness 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 approaches to safely, effectively, and sustainably treat and maintain weight. MCR4 agonism is a Our research and emerging clinical data show that combining MCR4 agonists with incretin therapeutics can result in weight loss effects the body in a low and well-tolerated dose,” said. Carl Span, Ph.D., President and CEO of Palatin. “We have extensive experience in obesity research, a center for new selective MCR4 agonists, and a convenient way to find bremelanotide, an FDA-approved MCR4 agonist. A treatment option for obesity.”

The story continues

Virtual KOL 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 and weight maintenance. The KOL event has features Jesse RichardsDO (Oklahoma State University College of Osteopathic Medicine), who will discuss the current state of obesity treatment, including the use of incretin therapeutics as a maintenance approach, and the unmet need for new, alternative therapies. activity, and combining a melanocortin agonist with incretins, such as GLP-1s, may improve treatment.

The KOL event will take place on 10:00 AM Eastern Time to May 8th^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 portfolio of scientific assets in the design and development of MCR4 agonists for use in the treatment of obesity. This includes specific MCR4 peptide agonists and small oral MCR4 agonists.

Palatin previously published a post presentation of preclinical data, entitled Melanocortin receptor 4 agonist PL8905 Combined with Glucagon Like Peptide-1 Produces Synergistic Weight Loss, Food Reduction, and Greater Glucose Regulation in Diet-Induced Obese (DIO) Rats. (Dodd et al.) at the Peptide Therapeutics Symposium, 16-17 October 2023 to La Jolla, CA.

GLP-1 agonists are currently the standard of care treatment for obesity. However, real-world usage data shows that more than two-thirds (68%) of obese patients stop using within the first year. Side effects, especially at high doses and the plateau effect, contribute to a high rate of discontinuation. Palatin’s new approach aims to solve these problems by improving treatment adherence and promoting long-term weight loss through combination therapy. By combining the MCR4 agonist with the GLP-1 agonist, Palatin expects to achieve significant weight loss at lower doses, with improved tolerance. Combination drug therapy will be an important part of improving health and quality of life in 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 showing statistically significant results in reducing food intake and weight loss in patients of obesity (published data; Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight in obese women: Data from a 2022 randomized controlled trial; 1-10 doi: 10.1111/ dom.14672 available at www.Palatin.com.

Regarding Melanocortin Receptor 4 Agonists Effect on Obesity
Genetic analysis has identified that melanocortin receptor 4 (MCR4) of the paraventricular nucleus of the hypothalamus plays an important role in the regulation of appetite. Genetic mutations that inhibit signaling in the MCR4 pathway lead to hyperphagia, reduced energy expenditure and early obesity; such changes have been identified as the cause of several rare genetic diseases of obesity. Agouti-related peptide is an endogenous antagonist of MCR4 that works with neuropeptide Y to stimulate appetite, while MCR4 agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of MCR4 therefore represents an attractive target for the potential treatment of obesity.

About Obesity
Obesity, defined as a body mass index (BMI) ≥30 kg/m2, is a growing global public health problem. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, heart disease, stroke and some types of cancer. Health-related quality of life is significantly reduced among obese adults, and obesity is associated with increased use of health care resources and higher economic burden. Therefore, safe and effective obesity treatment remains an important unmet need. The global increase in the prevalence of obesity is a public health issue with significant costs to health care systems. To United Statesaround 42% of adults are obese, and one in five young people between the ages of 12-19 are obese.

About the Palatine
Palatin is a biopharmaceutical company that develops first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, with a target audience of a specific product for the treatment of diseases with a need great unattainable medical and business potential. Palatin’s strategy is to develop products and create marketing partnerships with industry leaders to expand their business capabilities. To learn more about Palatin, please 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 future expectations of Palatin Technologies, Inc., such as statements about Palatin’s products in development, clinical trial results, actions can be done by regulatory agencies including the FDA, regulatory projects, development programs. , the proposed benchmarks for the product candidates, and the market prospects for the 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 harbor created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to differ materially from historical results or any expressed or implied results. such statements are forward looking. Palatin’s actual results may differ materially from those expressed in 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. management, Palatin’s ability to support financial development. of its technology and to establish and successfully complete clinical trials, the length of time and costs required to complete clinical trials and submit applications for regulatory approval, products made by competing pharmaceutical companies, biopharmaceutical and biotechnology, commercial acceptance of Palatin products, and other issues discussed. in Palatin’s periodic reports with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this announcement.

Palatine Technologies^® is a registered trademark of Palatin Technologies, Inc.

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