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Palatin Technologies : First Patient Dosed in Phase 2 Clinical Study of Palatin's Bremelanotide Co-Administered with Tirzepatide (GLP-1) for the Treatment of Obesity

Published 22/08/2024, 12:34

PTN
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Palatin Technologies (NYSE:PTN), 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 patient dosing has started for the clinical 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 (ClinicalTrials.gov Identifier: NCT06565611).

"We are excited with the start of patient dosing and by the level of patient and physician interest in our Phase 2 clinical study of an MCR4 agonist plus a GLP-1 to treat obese patients." said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The safe, effective, and consistent treatment and maintenance of weight loss will require multiple therapeutic options with differing mechanisms of action. The MCR4 pathway plays a key role in the regulation of energy storage and food intake, and we see MCR4 agonists playing an important role in future combination therapies and are advancing our novel long-acting peptide and small molecule compounds as key possible components of such combinations."

"The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year. This often results in a rebound effect with patients gaining back significant weight. Our research coupled with 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."

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The study is designed to enroll up to 60 patients at four trial sites in the United States with the primary endpoint of the trial 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.

Full patient enrollment in this Phase 2 clinical study of BMT-801 is currently expected in the third quarter of calendar year 2024 with topline data readout expected in the first half of calendar year 2025.

About Melanocortin 4 Receptor Agonists Effect on Obesity

Genetic analysis has identified the melanocortin 4 receptor (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 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, MCR1 through MCR5. 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.

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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.

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