Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

Core Insights - Palatin Technologies, Inc. is advancing multiple clinical programs targeting significant medical needs, including dry eye disease, obesity, male sexual dysfunction, and ulcerative colitis [1][2][3] Ocular Programs - The Phase 3 clinical program for PL9643 in treating dry eye disease (DED) is set to begin patient enrollment in Q4 2024, with topline results expected in Q4 2025 [1][3] - A positive Type C meeting with the FDA confirmed the trial protocols and endpoints for the MELODY-2 and MELODY-3 studies [2][3] - The successful completion of the Phase 3 MELODY-1 study demonstrated statistical significance for multiple symptom endpoints, indicating the efficacy of PL9643 [3][4] Obesity Program - A Phase 2 clinical study combining melanocortin-4 receptor (MC4R) agonist bremelanotide with GLP-1 (tirzepatide) commenced patient dosing in Q3 2024, with topline results expected in Q1 2025 [1][4] - The study aims to enroll up to 60 patients across four sites in the U.S., focusing on safety and efficacy in weight reduction [4] Male Sexual Dysfunction Program - Development of bremelanotide co-formulated with a PDE5 inhibitor for erectile dysfunction (ED) is underway, with a pharmacokinetics study expected to start in Q1 2025 and patient recruitment anticipated in H2 2025 [1][5] - Approximately 35% of men with ED do not respond adequately to PDE5i treatments, representing a significant market opportunity [5] Ulcerative Colitis Program - The Phase 2 clinical study of oral PL8177 for ulcerative colitis is ongoing, with an interim analysis expected in Q4 2024 and topline results anticipated in Q1 2025 [1][6] Financial and Strategic Developments - The company is engaged in discussions for potential collaborations and funding to support the development of its clinical programs [1][2][6] - An asset sale of Vyleesi® to Cosette Pharmaceuticals for up to $171 million was completed in December 2023, retaining rights for bremelanotide in obesity and male erectile dysfunction [6][7]