FDA Approves Bremelanotide-Tirzepatide Combo for Obesity Trial

Palatin Technologies, a biopharmaceutical firm, is set to initiate a Phase 2 clinical trial mid-2024, following FDA approval of its IND application for bremelanotide, an MCR4 agonist, used alongside tirzepatide for obesity treatment. The trial will assess the safety and efficacy of the combined therapy in reducing body weight and is expected to report topline data by the end of 2024.

The study will involve approximately 60 participants already receiving tirzepatide at five U.S. sites. After a four-week tirzepatide-only period, eligible patients will be randomized into four treatment groups. The trial's primary goal is to establish the safety and increased effectiveness of the combined treatment.

Palatin's President and CEO, Carl Spana, highlighted the importance of multiple pathways for treating obesity, noting that MCR4 agonism is a validated weight loss mechanism. He expressed optimism about the FDA's approval to further investigate melanocortin agonists as potential obesity treatments, leveraging the company's expertise and access to bremelanotide.

On May 8, 2024, Palatin will host a virtual KOL event, "Beyond GLPs," discussing the metabolic program and the role of novel MCR4 agonists in obesity and weight loss maintenance. The event will feature Jesse Richards, DO, who will explore the current obesity treatment landscape and the potential of combining melanocortin agonists with incretins for optimized treatment.

Palatin's experience and intellectual property in MCR4 agonist development are significant, including both peptide and oral small molecule agonists. The company has previously presented data on the synergistic weight loss effects of combining MCR4 agonists with GLP-1, and it aims to improve treatment adherence and promote long-term weight loss through combination therapy.

MCR4 agonists are considered promising for obesity treatment due to their role in appetite regulation. Genetic mutations affecting MCR4 signaling can lead to increased appetite and obesity. MCR4 agonists, therefore, could offer an effective treatment approach.

Obesity, defined by a BMI of 30 kg/m2 or higher, is a growing health concern linked to various health risks and reduced quality of life. Safe and effective treatments are urgently needed to address the rising prevalence of obesity and its impact on healthcare systems.

Palatin is focused on developing first-in-class medicines that modulate melanocortin receptor activity, targeting diseases with significant unmet needs. The company aims to collaborate with industry leaders to maximize the commercial potential of its products.