Palatin Technologies has completed its Phase II study, BMT-801, evaluating the joint administration of melanocortin 4 receptor (MC4R) bremelanotide with tirzepatide, a glucagon-like peptide-1 (GLP-1)/gastric inhibitory polypeptide (GIP), to treat obesity.
The final output collection and quality control will be completed soon, with top-line data anticipated later during this quarter.
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A total of 113 subjects were enrolled in the trial, significantly surpassing the initial goal of 60 subjects, due to ‘strong’ subject demand and the ‘efficiency’ at the four trial centres in the US. Out of these, 96 subjects were randomised.
Determining the efficacy and safety of the joint combination in decreasing body weight is the trial’s primary endpoint.
Subjects initially received treatment involving tirzepatide alone for four weeks, and their eligibility was confirmed. They were later randomised into one of four treatment protocols.
The study included several evaluations of efficacy and safety to outline the ‘effectiveness’ of bremelanotide as both a stand-alone treatment and with GLP-1/GIP therapy for general obesity.
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By GlobalDataPalatin Technologies CEO and president Carl Spana said: “We believe the data from this study will demonstrate that the combination of MC4R and 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.”
The MC4R of the paraventricular nucleus of the hypothalamus is known to play a central role in appetite regulation.
Genetic mutations that block signalling in the MC4R pathway can result in hyperphagia, reduced energy expenditure, and early-onset obesity.
The melanocortin receptor system has been found to influence the intake of food, immune system responses, metabolism, sexual function, and inflammation.
In June 2024, the company announced the start of a Phase II trial evaluating the co-administration of bremelanotide and a phosphodiesterase 5 inhibitor (PDE5i) for treating erectile dysfunction.
