Palatin Technologies, Inc. (NYSE American: PTN), a US-based biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced on Wednesday the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity.

The clinical study will evaluate the safety and efficacy of bremelanotide, a melanocortin 4 receptor (MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in obese patients. The primary endpoint of the trial is to demonstrate the safety and increased efficacy of the co-administration of bremelanotide with tirzepatide on reducing body weight. Topline data results are expected by the end of calendar year 2024.

'Although GLP-1 agonists are currently the standard of care treatment for obesity, data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year,' said Carl Spana, Ph.D., Palatin CEO and president. 'We believe co-administering an MC4R agonist with a GLP-1 agonist will achieve significant weight loss at lower doses, with improved tolerability and quality of life for these patients. These beliefs are supported by our published preclinical data and multiple clinical studies demonstrating statistically significant effects on reducing food intake and weight loss in obese patients.'

The clinical study, titled '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' has Food and Drug Administration clearance. The study is designed to enroll up to 60 patients who are actively on tirzepatide at five trial sites in the United States. 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.