Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity
Palatin Technologies, Inc. (NYSE American: PTN) has received FDA clearance to begin a Phase 2 clinical study for the co-administration of bremelanotide with tirzepatide for treating obesity. The study is expected to start in mid-2024 with data by the end of the year. The company is hosting a virtual KOL event on May 8, 2024, to discuss its metabolic program.
FDA clearance for Phase 2 clinical study for co-administration of bremelanotide with tirzepatide for obesity treatment.
Hosted a virtual KOL event to discuss metabolic program and potential treatments for obesity.
Palatin has significant experience and an extensive intellectual property portfolio in the design and development of MCR4 agonists for obesity treatment.
Real-world data shows high discontinuation rates for GLP-1 agonists for obesity treatment.
Obesity is associated with serious health conditions and high economic burden, indicating a critical unmet need for effective treatments.
- Phase 2 clinical study expected to begin in mid-calendar year 2024
- Topline data expected by calendar year-end 2024
- Hosting virtual KOL event "Beyond GLPs" on May 8, 2024
- Focus will be on Company's metabolic program and the multiple roles for novel melanocortin receptor 4 agonists in treating obesity and weight loss maintenance
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-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity" has been reviewed by FDA with an approval to proceed under Palatin's IND. The study is designed to enroll up to 60 patients actively on tirzepatide at approximately five trial sites in the
"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 Carl Spana, Ph.D., President and CEO of Palatin. "We have extensive experience in obesity research, a portfolio of novel selective MCR4 agonists, and ready access to bremelanotide, an FDA approved MCR4 agonist. We are excited by the FDA's acceptance of our IND to further study the utility of melanocortin agonists as a potential treatment option for obesity."
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 Jesse Richards, DO (Oklahoma State University College of Osteopathic Medicine), who will discuss the current treatment landscape for obesity, including the use of incretin therapeutics as the standard of care, and the unmet need for new treatments with alternative mechanisms of action, and how combining a melanocortin agonist with incretins, like GLP-1s, can optimize treatment.
The virtual KOL event will take place at 10:00 AM Eastern Time on May 8th. A live question and answer session will follow the formal presentations. To register for the event, please click here.
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, October 16-17, 2023 in
GLP-1 agonists are currently the standard of care treatment for obesity. However, real-world use data shows that more than two-thirds (
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 (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).
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 α- and β-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. 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.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.
FAQ
<p>When will Palatin's Phase 2 clinical study for obesity treatment begin?</p>
The Phase 2 clinical study is expected to begin in mid-2024.
<p>What is the focus of Palatin's virtual KOL event on May 8, 2024?</p>
The event will discuss the metabolic program and potential treatments for obesity.
<p>What is the significance of FDA clearance for the co-administration study of bremelanotide with tirzepatide?</p>
The FDA clearance allows Palatin to evaluate the safety and efficacy of the combined treatment for obesity.
<p>What is the current standard of care for obesity treatment?</p>
GLP-1 agonists are currently the standard of care, but real-world data shows high discontinuation rates.
<p>What are the key goals of Palatin's obesity treatment approach?</p>
The company aims to improve treatment adherence, promote consistent weight loss, and address side effects through combination therapy.
