Palatin: Bremelanotide with Tirzepatide Hits Primary Endpoint in Phase 2 Obesity Study

Palatin Technologies, Inc., a biopharmaceutical firm renowned for developing innovative medicines targeting the melanocortin receptor system, has announced groundbreaking results from its BMT-801 Phase 2 study aimed at obesity treatment. The study, which explored the effects of co-administering the melanocortin-4 receptor (MC4R) agonist bremelanotide with tirzepatide, a glucagon-like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP), achieved remarkable success in meeting its primary endpoint. The results showcased a notable reduction in weight among participants, marking a significant advancement in obesity treatment techniques.

The 8-week research involved administering lower doses of both bremelanotide and tirzepatide, yielding highly significant statistical outcomes. The co-administered group experienced a 4.4% decrease in weight, a figure notably higher than the 1.6% reduction observed in the placebo group. Further analysis revealed additional promising data: 40% of individuals receiving combined treatment achieved a 5% weight reduction, compared to 27% in the placebo cohort. Moreover, 27% saw a 6% decrease, while 19% achieved a 7% reduction, illustrating the additive and synergistic effects of the treatment combination.

An intriguing aspect of the study was the ability of low-dose bremelanotide to prevent the rapid weight regain typically seen after stopping tirzepatide. This suggests the co-administered regimen not only enhances weight loss but also maintains it beyond the cessation of GLP-1/GIP therapy. Jesse Richards, DO, highlighted the importance of the findings, emphasizing the synergistic effects of combining MC4R agonists with GLP-1/GIP compounds, a combination that aligns with clinical observations for treating severe genetic obesity.

The study enrolled 113 patients, with 96 randomly divided into four treatment groups following initial eligibility confirmation via a four-week tirzepatide treatment. Participants were assigned to either co-administered MC4R and GLP-1/GIP treatment, tirzepatide alone, bremelanotide alone, or placebo. The research found that weight regain after treatment discontinuation was halted specifically in the MC4R agonist group, indicating a potential breakthrough in long-term weight management.

Palatin Technologies is progressing with its development of next-generation MC4R long-acting peptides and oral small molecules. Plans are underway for Investigational New Drug applications by late 2025, with clinical data expected in 2026. These compounds are being explored for their potential in treating various forms of obesity, including genetically driven disorders. The company is committed to addressing the unmet needs in obesity treatment, leveraging its expertise in MC4R pathway interactions.

Obesity treatments currently face challenges such as side effects and cost, often leading to discontinued use and weight regain. MC4R agonists present an alternative pathway with promising therapeutic potential. Genetic studies have identified the MC4R as a key player in appetite regulation, with mutations leading to severe obesity. MC4R agonists counteract this by promoting satiety, making them attractive targets for obesity treatment.

Palatin Technologies continues to innovate in the biopharmaceutical landscape, developing receptor-specific treatments for diseases with significant unmet needs. Their strategy involves not only developing novel treatments but also forming strategic partnerships to maximize commercial potential. As the company advances its research, it remains focused on redefining treatment standards and addressing the diverse challenges associated with obesity management.