Palatin Technologies has completed its Phase 2 BMT-801 clinical study of the co-administration of MC4R bremelanotide + GLP-1/GIP tirzepatide for the treatment of obesity. Final data collection and quality control will conclude shortly.
Topline data results from the Phase 2 BMT-801 entitled “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” are expected later to be reported by the end of the first quarter of 2025. The study enrolled a total of 113 patients, with 96 patients randomized. The patient enrolment number is approximately twice the initial target of 60 patients, primarily due to strong patient demand and efficiency at the four US clinical trial sites.
The primary endpoint of the Phase 2 BMT-801 clinical trial is to demonstrate the safety and efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. Patients were treated with tirzepatide-only for four weeks, had eligibility confirmed, then were randomized to one of four treatment regimens. Patients underwent 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.
“We believe the data from this study will demonstrate that the combination of MC4R + GLP-1/GIP agonists may result in additive and synergistic effects on patient weight loss, and importantly, will inform and support our planned clinical programmes and development programmes under assessment for treating general obesity, weight loss management, acquired and congenital hypothalamic obesity, and potentially, rare/orphan genetically caused MC4R pathway diseases,” said Dr Carl Spana, President & Chief Executive Officer of Palatin. “There is a clear and unmet medical need for alternative mechanisms of action that can provide physicians and patients with improved overall health outcomes in the pursuit of weight loss beyond those achieved with GLP-1 and GIP drugs. The MC4R pathway plays a key role in eating behavior and how our bodies manage energy. As a result, we believe that MC4R agonists, especially the highly selective MC4R long-acting peptides and oral small molecule agonists we are developing, will play an important role for treating obesity as monotherapy and/or combination therapy.”
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