Palatin Initiates Phase 2 Clinical Study of Bremelanotide for the Treatment of Obesity

• Co-Administration Phase 2 study of bremelanotide with tirzepatide (GLP-1) to provide key information for melanocortin treatments of obesity
• Topline data expected by end of calendar year 2024
• Additional studies under assessment for multiple metabolic conditions

CRANBURY, N.J., June 12, 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 the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity. The clinical study will evaluate the safety and efficacy of bremelanotide, a melanocortin 4 receptor (MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in obese patients. The primary endpoint of the trial is to demonstrate the safety and increased efficacy of the co-administration of bremelanotide with tirzepatide on reducing body weight. Topline data results are expected by the end of calendar year 2024.

"Although GLP-1 agonists are currently the standard of care treatment for obesity, data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year," said Carl Spana, Ph.D., CEO and President of Palatin. "We believe co-administering an MC4R agonist with a GLP-1 agonist will achieve significant weight loss at lower doses, with improved tolerability and quality of life for these patients. These beliefs are supported by our published preclinical data and multiple clinical studies demonstrating statistically significant effects on reducing food intake and weight loss in obese patients."

Dr. Spana added, "The MC4R pathway biology is clear and strong. It regulates hunger, caloric intake, energy expenditure and, consequently, body weight. Obesity has a tremendous adverse impact on patients, their families, and across the medical community. With significant experience and an extensive intellectual property portfolio in the design and development of MC4R agonists, Palatin continues to develop novel and highly selective MC4R agonists, including oral small molecule MC4R agonists, for the potential treatment of multiple metabolic indications, including certain rare genetic diseases of obesity."

The clinical study, titled "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" has Food and Drug Administration clearance. The study is designed to enroll up to 60 patients who are actively on tirzepatide at five trial sites in the United States. 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.

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. 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.

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SOURCE Palatin Technologies, Inc.