• Topline results expected in 1Q calendar year 2025
  
• Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight
  
• Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesity

CRANBURY, N.J., Oct. 31, 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 (MCR) system, today announced it has completed enrollment in the study entitled "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."

The study enrolled approximately twice the target of 60 patients at four US sites, primarily due to strong patient demand and efficiency of the clinical trial sites. All patients in the study are expected to have completed all dosing and patient visits by the end of January 2025, with topline data readout expected before the end of March 2025.

"We believe the study data will demonstrate that combination of an MC4R agonist, such as bremelanotide, with a glucagon-like peptide 1/gastric inhibitory polypeptide (GLP-1/GIP), such as 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 Chief Executive Officer of Palatin. "We believe the data from this MC4R + GLP-1/GIP combination study will inform and support our programs for treating general obesity, weight loss management, and potentially, rare/orphan MC4R pathway diseases, including hypothalamic obesity."

Dr. Spana added, "Weight loss is quick and substantial with GLP-1/GIP therapies, but both healthcare professionals and patients are seeking alternative treatments to these therapies due to 67% of patients discontinuing treatment because of side effects and a plateau effect in the first year. This often results in a rebound effect, with patients gaining back significant weight. The MC4R pathway plays a key role in eating behavior and how our bodies manage energy, and we believe that MC4R agonists, especially highly selective MC4R agonists being developed by Palatin, will play an important role for treating obesity as monotherapy and/or combination therapy.

The primary endpoint of the BMT-801 trial is to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. Patients are treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens. Patients 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. Additional trial information can be found at https://clinicaltrials.gov via the identifier NCT06565611.

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 Melanocortin Receptor Agonists

The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

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 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 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.