Palatin Receives FDA Clearance for Bremelanotide and Tirzepatide Co-Administration IND for Obesity Treatment

Palatin Technologies, Inc., a biopharmaceutical firm based in Cranbury, N.J., is advancing its research on obesity treatment with novel medications targeting the melanocortin receptor system. The U.S. Food and Drug Administration (FDA) has concluded its 30-day review of Palatin's investigational new drug (IND) application for bremelanotide, an MCR4 agonist intended for obesity therapy. The FDA's green light allows Palatin to commence a Phase 2 clinical study in mid-2024, with initial results expected by year-end.

The forthcoming clinical trial is designed as a randomized, double-blind, placebo-controlled study. It aims to enroll up to 60 patients currently undergoing tirzepatide treatment across five U.S. sites. The primary objective is to evaluate the safety and enhanced efficacy of the combined administration of bremelanotide and tirzepatide in reducing body weight. Participants will initially receive tirzepatide-only for four weeks before randomization into one of four different treatment regimens. Multiple assessments will measure both safety and efficacy, providing insights into the potential benefits of bremelanotide either as a stand-alone or in combination with GLP-1/GIP therapy.

Carl Spana, Ph.D., President and CEO of Palatin, highlighted the significance of this study in addressing obesity through multiple therapeutic pathways. He emphasized that MCR4 agonism is a validated method for weight reduction, and combining it with incretin therapies like tirzepatide could yield synergistic effects, leading to improved weight loss at more tolerable doses.

In addition to the clinical trial, Palatin will host a virtual Key Opinion Leader (KOL) event titled "Beyond GLPs" on May 8, 2024. This event will spotlight the company's metabolic program and the versatile roles of MCR4 agonists in treating obesity and supporting weight loss maintenance. Jesse Richards, DO, from Oklahoma State University College of Osteopathic Medicine, will discuss the current obesity treatment landscape and the need for innovative approaches. The event will include a live Q&A session following the presentations.

Palatin has a robust background in obesity research, supported by an extensive portfolio of selective MCR4 agonists, including both peptide and small molecule formulations. Previously, the company presented preclinical data indicating that the combination of MCR4 agonist PL8905 with GLP-1 results in significant weight loss, reduced food intake, and better glucose control in diet-induced obese rats.

Current treatments for obesity, predominantly GLP-1 agonists, face a high discontinuation rate due to side effects and plateau effects. Approximately 68% of patients stop using these treatments within the first year. Palatin's innovative approach aims to enhance patient adherence and achieve consistent long-term weight loss through combination therapy. By integrating an MCR4 agonist with a GLP-1 agonist, the goal is to attain substantial weight loss at lower, more manageable doses, ultimately improving patient health and quality of life.

Genetic studies have pinpointed the MCR4 in the hypothalamus as a crucial regulator of appetite. Mutations affecting MCR4 signaling can lead to early-onset obesity due to increased appetite and reduced energy expenditure. MCR4 agonists, like α- and β-melanocyte-stimulating hormones, promote satiety, making them promising targets for obesity treatment.

Obesity, defined by a BMI of 30 kg/m² or greater, is a growing global health issue associated with various serious conditions, including cardiovascular diseases, type 2 diabetes, and certain cancers. In the U.S., about 42% of adults and one in five teens are affected. Effective and safe obesity treatments are thus a critical unmet need.

Palatin Technologies continues to develop cutting-edge medicines targeting the melanocortin receptor systems, aiming to address diseases with significant unmet needs. The company's strategy involves developing these products to a stage where they can be marketed in collaboration with industry leaders, maximizing their commercial potential.