Palatin Announces Positive Appetite Suppression Results from Phase 2 Obesity Study

Palatin Technologies, Inc., a New Jersey-based biopharmaceutical company, has announced promising results from its Phase 2 trial of BMT-801, focusing on its novel obesity treatment. The study investigated the effects of a combination therapy using bremelanotide and tirzepatide, as well as each drug individually, on appetite suppression and weight management.

Bremelanotide is a melanocortin 4 receptor (MC4R) agonist, while tirzepatide is known for its dual role as a glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. Together, they form a potent therapeutic approach aimed at regulating appetite and facilitating weight loss.

The trial showed that co-administration of bremelanotide and tirzepatide resulted in significant improvements in appetite control, including heightened feelings of fullness and satiety among participants. Both drugs were also tested separately, and results indicated that bremelanotide matched or surpassed tirzepatide in appetite suppression. Additionally, patients who continued on bremelanotide after stopping tirzepatide maintained their weight loss without significant rebound, highlighting bremelanotide's potential in sustaining long-term weight management.

In terms of quantitative outcomes, the patients receiving the combination therapy reported a 71% increase in appetite suppression. When administered alone, tirzepatide also showed a 73% increase, and bremelanotide led to a 71% increase. Evaluating the sense of fullness, bremelanotide alone recorded a 79% improvement, outperforming the combination therapy’s 65% and tirzepatide’s 62%. Similarly, for satiety, bremelanotide alone showed a 68% increase compared to the 56% increase observed in both the combination therapy and tirzepatide alone.

A notable finding was the diminished weight rebound effect when transitioning from tirzepatide to bremelanotide, emphasizing the MC4R agonist’s role in long-term weight maintenance. This outcome is significant, given the typical challenge of weight regain after ceasing GLP-1/GIP therapies.

The initial results, released previously, established that bremelanotide combined with tirzepatide achieved statistically significant weight reduction compared to a placebo over an eight-week treatment period. Further insights into secondary measures, such as body composition and body mass index (BMI), are still being analyzed.

Looking ahead, Palatin plans to present comprehensive findings at an upcoming medical conference. Additionally, the company continues to advance its development pipeline, focusing on next-generation MC4R agonists, including long-acting peptides and oral small molecules. These developments target broader obesity indications, paving the way for potential treatments of genetic and rare obesity disorders, like hypothalamic obesity. Investigational New Drug (IND) applications are expected by the end of 2025, with initial clinical data anticipated in the first half of 2026.

The MC4R plays a crucial role in appetite regulation, as genetic mutations in this pathway can lead to overeating, reduced energy expenditure, and early-onset obesity. By targeting this receptor, Palatin aims to address significant unmet medical needs in the obesity treatment landscape. With these promising trial results, Palatin is strategically positioned to further explore and develop innovative therapies to combat obesity and its related disorders.