Palatin Technologies, Inc. announced it has initiated a clinical development program evaluating bremelanotide, a melanocortin receptor 4 (MCR4) agonist, co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy. Published clinical data of the use of bremelanotide and PDE5i drugs in ED patients, provides support that the combination of bremelanotide with a PDE5i, two active ingredients that act by different and distinct mechanisms of action, into a single drug product, has the potential to be synergistic, at lower doses, thereby reducing the potential for side effects. Working with a collaborator, Palatin has developed a co-formulation of bremelanotide and a PDE5i which can be administered as a single injection.

The initial trial for the clinical development program for this novel co-formulation will be a Phase 2 clinical study of bremelanotide co-administered with a PDE5i in ED patients who have not responded to PDE5i treatment. This study is currently expected to start in the fourth quarter of the calendar year 2023. Bremelanotide (1.75mg) is the active agent in Vyleesi®?, approved by the U.S. Food and Drug Administration (FDA) for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD).

As the first company to gain FDA approval for a melanocortin receptor molecule (Vyleesi for HSDD), Palatin has extensive expertise in the design and development of melanocortin- based therapeutics and the clinical development, regulatory approval and commercialization of treatments for sexual dysfunction. Bremelanotide has been evaluated as a treatment for men with ED in numerous clinical studies demonstrating statistically and clinically significant improvements in their erectile function. There are limited therapeutic options for ED patients non-responsive to phosphodiesterase-5 inhibitor therapy, including alprostadil for direct penis injection or urethral suppositories, surgical penile implants and various devices.