Palatin Technologies, Inc. announced that its BMT-801 Phase 2 obesity co-administration study met its primary endpoint and was highly statistically significant. The Company reported positive topline data with co-administered melanocortin-4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) tirzepatide and highlighted next steps in its obesity program for its novel next-generation MC4R long-acting peptides and oral small molecules.
"Although the study was not designed to optimize weight loss, this 8-week study utilizing low doses of both bremelanotide and tirzepatide, met the primary endpoint and was highly statistically significant," said Carl Spana, Ph.D., President & Chief Executive Officer of Palatin. "The positive results of this signal-generating study exceeded expectations. The data demonstrated that co-administration was additive and synergistic, resulting in increased weight loss, and that co-administration did not result in increased tolerability or safety issues for patients. The data also showed that low dose MC4R agonist bremelanotide stopped the rapid weight regain seen after ending GLP-1/GIP tirzepatide treatment."
Topline data results from the study were highly statistically significant for the study's primary endpoint, which was percent weight loss in patients for the co-administration of MC4R agonist bremelanotide plus GLP-1/GLP tirzepatide compared to placebo, over the 8-week treatment period.
- The co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001).
The primary analysis for additive effect demonstrated that:
- 40% of patients in the co-administered group achieved a 5% reduction in their body weight, compared to 27% for the tirzepatide alone group (p<0.05).
- 27% of patients in the co-administered group achieved a 6% reduction in their body weight, compared to 13% for the tirzepatide alone group (p<0.05).
- 19% of patients in the co-administered group achieved a 7% reduction in their body weight, compared to 0% for the tirzepatide alone group (p<0.1).
- Increase in the percent of subjects on co-administration achieving 5%, 6% and 7% weight loss over tirzepatide alone, indicates that co-administration had a synergistic effect.
"This study provides compelling evidence that combining an MC4R agonist with a GLP-1/GIP compound creates a synergistic effect on weight loss," said Jesse Richards, DO, of Oklahoma State University College of Osteopathic Medicine. "These findings align with what we observe in our clinic, where we treat patients with severe genetic obesity using both mechanisms. With a critical need for diverse weight loss solutions, this approach offers a promising improvement to GLP-1/GIP monotherapy, particularly for those who struggle with tolerability at high doses."
In the study, patients first received a four-week treatment with tirzepatide alone (2.5 mg weekly) to confirm eligibility. They were then randomly assigned to one of four treatment groups for an additional four weeks: co-administration of MC4R bremelanotide (1.25 mg daily) and GLP-1/GIP tirzepatide (2.5 mg weekly), tirzepatide alone (2.5 mg weekly), bremelanotide alone (1.25 mg daily), or a placebo. A total of 113 patients were enrolled, with 96 randomized in a 3:1 ratio. Specifically, 46 patients were assigned to the MC4R plus GLP-1/GIP co-administration group, while the remaining arms had 15 to 16 patients each.
More than 50% of the lost weight was regained within two weeks after treatment cessation in both the co-administration group and the tirzepatide-only group, a common occurrence following the discontinuation of GLP-1/GIP therapy. Importantly, the data indicated that weight regain was effectively halted in the MC4R agonist bremelanotide group. Additionally, co-administration of the MC4R agonist with the GLP-1/GIP therapy showed no increase in safety or tolerability concerns among patients.
Further data analysis is ongoing, including exploratory endpoints such as body composition and body mass index (BMI). The complete study results will be presented at an upcoming medical conference.
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