Zealand Pharma and Palatin Technologies are making significant strides in their respective pipelines targeting obesity and related metabolic diseases. Both companies have recently announced key milestones in their clinical development programs, signaling potential advancements in the treatment landscape for these prevalent conditions.
Zealand Pharma's Obesity Pipeline Momentum
Zealand Pharma A/S (Nasdaq: ZEAL) is focused on peptide-based medicines, announced its financial results for the full year 2024, highlighting clinical advancements in its obesity pipeline. Adam Steensberg, President and Chief Executive Officer at Zealand Pharma, noted that 2024 was a transformational year with positive data and significant capital raised to further invest in the company's pipeline.
Petrelintide Development
Petrelintide, a long-acting amylin analog, demonstrated positive results in a 16-week Phase 1b trial. Following this, Zealand Pharma initiated ZUPREME-1, a comprehensive Phase 2b trial in overweight or obese individuals, with participant enrollment expected to complete in the first half of 2025. The company also plans to initiate ZUPREME-2, a Phase 2b trial in overweight or obese patients with type 2 diabetes, in the first half of 2025.
Dapiglutide Advancement
Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist, showed positive topline results from a 13-week Phase 1b trial. These results support the advancement of dapiglutide into a large Phase 2b trial in overweight or obese individuals, planned for initiation in the first half of 2025. The Phase 1b trial was expanded to evaluate higher doses over a longer treatment period, with topline results expected in the first half of 2025.
Survodutide Progress with Boehringer Ingelheim
Survodutide, a glucagon/GLP-1 receptor dual agonist partnered with Boehringer Ingelheim, reported positive results from a Phase 2 trial in MASH (metabolic dysfunction-associated steatohepatitis). The U.S. FDA granted Survodutide Breakthrough Therapy Designation. Boehringer Ingelheim has initiated two Phase 3 trials: LIVERAGE™ in people with moderate or advanced liver fibrosis (stages 2 or 3) and LIVERAGE™-Cirrhosis in people with compensated cirrhosis (fibrosis stage 4). Participant enrollment was completed in 2024 for the Phase 3 trials SYNCHRONIZE™-1 and SYNCHRONIZE™-2, evaluating survodutide in overweight or obese individuals, with and without type 2 diabetes, respectively.
Palatin Technologies Focuses on Melanocortin Receptor Agonists
Palatin Technologies Inc. (NYSE American: PTN) is advancing its melanocortin receptor (MCR) programs, particularly in obesity. Carl Spana, Ph.D., President and Chief Executive Officer of Palatin, highlighted the high discontinuation rate (67%) of obese patients on current therapies due to side effects and weight-loss plateau, emphasizing the need for additional safe and effective treatments.
BMT-801 Phase 2 Trial
Palatin expects topline results from its Phase 2 BMT-801 clinical study in the first quarter of 2025. This trial evaluates the co-administration of bremelanotide, an MC4R agonist, with tirzepatide, a GLP-1/GIP dual agonist, to reduce body weight. The primary objective is to demonstrate the safety and significant effect of this combination on weight reduction.
Future Clinical Trials
Palatin is planning multiple clinical trials in the second half of 2025, utilizing a novel long-acting MC4R peptide and/or an MC4R selective oral small molecule compound. These trials will target general obesity, weight loss management, and obesity associated with rare neuroendocrine and genetic diseases, including hypothalamic obesity.
The Role of MC4R Agonists in Obesity Treatment
Genetic analysis has identified the melanocortin 4 receptor (MC4R) as a central regulator of appetite. Mutations inhibiting the MC4R pathway can lead to hyperphagia, decreased energy expenditure, and early-onset obesity. Palatin's development of MC4R agonists aims to address these underlying genetic factors, potentially offering a more targeted approach to obesity treatment, either as monotherapy or in combination with existing treatments like GLP-1 agonists.
