Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED)

Core Insights - Approximately 30-40% of erectile dysfunction (ED) patients do not respond to phosphodiesterase-5 inhibitors (PDE5i) monotherapy, which includes drugs like Viagra, Cialis, and Levitra, indicating a significant unmet medical need for more effective treatments [2][4] - Palatin Technologies is developing a new co-formulation of bremelanotide (BMT) and a PDE5i, which is expected to be more effective for ED patients who do not respond to existing PDE5i therapies [3][8] - A Phase 2 clinical study of this co-formulation is currently underway, with topline data expected by the end of 2024, and a Phase 3 study anticipated to start in the first half of 2025 [1][9] Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor systems, targeting diseases with significant unmet medical needs [5] - The company aims to maximize the commercial potential of its products through marketing collaborations with industry leaders [5] Clinical Study Details - The Phase 2 clinical trial is designed to enroll approximately 50 patients who are non-responders to PDE5i monotherapy, assessing the safety and efficacy of BMT co-administered with a PDE5i [9] - Previous studies have shown that bremelanotide has statistically significant and clinically meaningful effects on improving erectile function [10]