The Company is cleared 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. The Phase 2 clinical study is expected to start mid-calendar year 2024, with topline data results by the end of calendar year 2024.
Phase 2 Trial Design
The clinical study, 'A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-
'Therapeutic options for obesity treatment requires multiple pathways to safely, effectively, and consistently treat and maintain weight loss. MCR4 agonism is a well validated mechanism for weight loss. Our research and 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,' said
Virtual KOL Event
The event will focus on the Company's metabolic program evaluating novel selective melanocortin receptor 4 agonists (MCR4) as effective and safe treatment for obesity and weight loss maintenance. The KOL event features
The virtual KOL event will take place at
Palatin has significant experience and an extensive intellectual property portfolio in the design and development of MCR4 agonists that can be used as treatments for obesity. This includes novel selective MCR4 peptide agonists and oral small molecule MCR4 agonists.
Palatin previously 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,
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 MCR4 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.
The use of combination therapy is supported by preclinical data with MCR4 agonist PL8905 and two previous clinical studies with MCR4 agonist bremelanotide demonstrating statistically significant effects on reducing food intake and weight loss in obese patients.
About Melanocortin Receptor 4 Agonists Effect on Obesity
Genetic analysis has identified the melanocortin receptor 4 (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 - and -melanocyte-stimulating hormone promote satiety. Agonism of the MCR4 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
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.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of
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