Palatin Technologies, Inc. (NYSE American: PTN) is making strides in its clinical programs, focusing on melanocortin receptor (MCR) modulation for ulcerative colitis and obesity. The company anticipates key data readouts in the near term for both its PL8177 and bremelanotide programs.
PL8177 Phase 2 Enrollment Complete for Ulcerative Colitis
Palatin Technologies announced the completion of patient enrollment in its Phase 2 study of PL8177, an orally administered melanocortin-1 receptor (MC1R) agonist, for the treatment of ulcerative colitis (UC). The multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of PL8177 in adult patients with active UC. Topline data is expected in the first quarter of 2025.
Carl Spana, Ph.D., President and CEO of Palatin, stated, "Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns."
Ulcerative colitis, a form of inflammatory bowel disease (IBD), affects an estimated 1.25 million individuals in the United States. Current treatments are not effective in a substantial portion of patients, and severe cases may result in surgical removal of the colon. PL8177 targets melanocortin-1 receptors on colon epithelial cells and has demonstrated sustained delivery to the colon lumen with no systemic exposure in a Phase 1 study.
The Phase 2 study, identified as NCT05466890 on clinicaltrials.gov, was designed to align with the latest FDA Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment (April 2022). The primary efficacy endpoint is the Mayo Endoscopic Subscore, which evaluates the level of disease in the colon mucosa.
Preclinical data has shown that oral PL8177 can improve inflamed colon health by repolarizing colon macrophages from a pro-inflammatory to a pro-inflammation resolving state.
Phase 2 Obesity Study Completed with Bremelanotide and Tirzepatide
Palatin Technologies also announced the completion of its Phase 2 BMT-801 clinical study, evaluating the co-administration of melanocortin 4 receptor (MC4R) bremelanotide with tirzepatide, a glucagon-like peptide-1 (GLP-1)/gastric inhibitory polypeptide (GIP) agonist, for the treatment of obesity. Topline data is expected later this quarter.
The study enrolled 113 patients, with 96 patients randomized, exceeding the initial target of 60 patients. The primary endpoint is to demonstrate the safety and efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. The trial, identified as NCT06565611 on clinicaltrials.gov, included multiple assessments of safety and efficacy to profile the effectiveness of bremelanotide as a stand-alone treatment or in conjunction with GLP-1/GIP therapy.
"We believe the data from this study will demonstrate that the combination of MC4R + GLP-1/GIP agonists may result in additive and synergistic effects on patient weight loss," said Dr. Spana. He further noted the potential for treating general obesity, weight loss management, acquired and congenital hypothalamic obesity, and rare/orphan genetically caused MC4R pathway diseases.
Genetic analysis has identified the melanocortin 4 receptor (MC4R) as playing a central role in appetite regulation. Agonists of the MC4R promote satiety, making it an attractive target for potential obesity treatments.
Palatin is also developing novel 'next generation' selective MC4R agonists, with investigational new drug (IND) enabling activities expected to commence this quarter.
About Palatin Technologies
Palatin Technologies is focused on developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, targeting diseases with significant unmet medical need and commercial potential. The company's strategy involves developing products and forming marketing collaborations with industry leaders to maximize their commercial potential.
