• Positive data with Palatin's melanocortin-4 receptor (MC4R) agonist plus glucagon like peptide-1 (GLP-1) presented at the Peptide Therapeutics Symposium
• GLP-1 & MC4R agonist co-administration data shows increased weight loss and greater glucose control above monotherapy
• Preclinical data and prior clinical studies support the further clinical development and commercial potential of Palatin's melanocortin agonists for obesity
• Clinical study currently expected to start 1Q calendar year 2024

CRANBURY, N.J., Oct. 18, 2023 /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 plans to initiate a clinical study of melanocortin 4 receptor (MC4R) agonist, bremelanotide, an FDA approved product and 100% owned by Palatin, in combination with a Glucagon Like Peptide-1 (GLP-1) agonist, in obese patients in the first quarter of calendar year 2024.  In addition, Palatin 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 MC4R 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.

"With the increased use of FDA-approved GLP-1 agonists for treating obesity there is an unmet need for treatments with alternative mechanisms of action that will help obese patients meet and maintain their weight loss objectives. We believe the MC4R agonist is the best validated mechanism for adjunctive therapy with GLP-1 agonists and weight loss maintenance," said Carl Spana, Ph.D., President and CEO of Palatin. "With our extensive experience in obesity research, a portfolio of novel selective MC4R agonists, and access to bremelanotide, an FDA approved MC4R agonist, we are well positioned to advance an MC4R agonist as a potentially effective and safe treatment for obesity."

The Peptide Therapeutics Symposium poster presented data evaluating the selective MCR4 agonist PL8905 from preclinical studies in which diet-induced obese animals were treated for 5 days with vehicle control, subcutaneous PL8905 alone and in combination with continuous infusion of a GLP-1 agonist.

• Vehicle control and infused GLP-1 alone slightly increased body weight.
• PL8905 monotherapy produced significant declines of 1.6% to 3.4% (P<0.01 vs vehicle).
• PL8905 combined with GLP-1, had larger declines in body weight than monotherapy of 2.9% to 5.1% (P<0.01).
• PL8905 combined with GLP-1 also showed a significant (P<0.01) reduction of blood glucose levels.

The use of combination therapy is supported by preclinical data with MC4R agonist PL8905 and two previous clinical studies with MC4R 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). 

Palatin has extensive experience and intellectual property in the design and development of MC4R agonists that can be used as treatments for obesity. This includes novel selective MC4R peptide agonists and oral small molecule MC4R agonists.

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 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. 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, such as statements about results and potential market for melanocortin receptor agonists in treating obesity, 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.            

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