First Patient Dosed in Phase 2 Clinical Study of Palatin's Bremelanotide Co-Administered with Tirzepatide (GLP-1) for the Treatment of Obesity

Core Insights - Palatin Technologies has initiated patient dosing for a Phase II clinical study (BMT-801) investigating the co-administration of Bremelanotide with Tirzepatide for obesity treatment, with full enrollment expected by Q3 2024 and topline results anticipated in Q1 2025 [1][3]. Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs and commercial potential [8]. Clinical Study Details - The Phase II study aims to enroll up to 60 patients across four sites in the U.S., with the primary endpoint being the safety and efficacy of the combination treatment in reducing body weight [2][3]. - Patients will initially receive Tirzepatide alone for four weeks before being randomized into one of four treatment regimens [2]. Mechanism of Action - The melanocortin 4 receptor (MCR4) is crucial for appetite regulation, and its agonists may provide a promising avenue for obesity treatment by promoting satiety [4][5]. - Combining MCR4 agonists with GLP-1 therapeutics like Tirzepatide may enhance weight loss effects while minimizing side effects, addressing the high discontinuation rates associated with current GLP-1 treatments [2]. Obesity Context - Obesity, defined as a BMI ≥30 kg/m², is a growing public health issue linked to various serious health conditions, with approximately 42% of U.S. adults and 20% of teens affected [7]. - The need for safe and effective obesity treatments is critical due to the associated economic burden on healthcare systems [7].