Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

Core Insights - Palatin Technologies has completed enrollment in its Phase 2 study of oral PL8177 for ulcerative colitis, which is expected to provide a safe and effective treatment option compared to existing therapies [1][2][3] - The study aims to evaluate the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of PL8177 in adult patients with active ulcerative colitis, with topline data anticipated in early 2025 [1][2][3] Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs [10] - The company aims to out-license its ulcerative colitis program, having received significant interest from multiple parties [2][3] Product Details - PL8177 is a potent melanocortin-1 receptor (MC1R) agonist that has shown promise in preclinical studies for resolving inflammation in ulcerative colitis [1][4][7] - The oral formulation of PL8177 demonstrated sustained delivery to the colon without systemic exposure, indicating a favorable safety profile [2][8] Clinical Study Design - The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled trial with a planned enrollment of 28 subjects, but was concluded early with 13 subjects due to strategic decisions [3] - The primary efficacy endpoint is the Mayo Endoscopic Subscore, which assesses the level of disease in the colon mucosa [3] Disease Context - Ulcerative colitis is a chronic inflammatory bowel disease affecting over 1 million people in the U.S., with existing treatments often ineffective for moderate-to-severe cases [2][9] - The disease can lead to severe complications, including surgery or cancer, highlighting the need for effective treatment options [2][9]