Palatin Technologies has completed enrolment in the study 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." The study enrolled approximately twice the target of 60 patients at four US sites, primarily due to strong patient demand and efficiency of the clinical trial sites. All patients in the study are expected to have completed all dosing and patient visits by the end of January 2025, with topline data readout expected before the end of March 2025.
The primary endpoint of the BMT-801 trial is to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. Patients are treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens. Patients 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.
"We believe the study data will demonstrate that combination of an melanocortin 4 receptor (MC4R) agonist, such as bremelanotide, with a glucagon-like peptide 1/gastric inhibitory polypeptide (GLP-1/GIP), such as tirzepatide, may result in synergistic effects on weight loss, allowing for increased weight loss at lower and better tolerated doses," said Dr Carl Spana, President and Chief Executive Officer of Palatin. "We believe the data from this MC4R + GLP-1/GIP combination study will inform and support our programs for treating general obesity, weight loss management, and potentially, rare/orphan MC4R pathway diseases, including hypothalamic obesity."
Genetic analysis has identified the MC4R of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signalling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MC4R therefore represents an attractive target for potential obesity treatments.
"Weight loss is quick and substantial with GLP-1/GIP therapies, but both healthcare professionals and patients are seeking alternative treatments to these therapies due to 67% of patients discontinuing treatment because of side effects and a plateau effect in the first year. This often results in a rebound effect, with patients gaining back significant weigh,” added Spana. “The MC4R pathway plays a key role in eating behaviour and how our bodies manage energy, and we believe that MC4R agonists, especially highly selective MC4R agonists being developed by Palatin, will play an important role for treating obesity as monotherapy and/or combination therapy.”
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