Palatin Technologies has announced the commencement of a Phase II clinical trial evaluating the co-administration of melanocortin 4 receptor (MC4R), bremelanotide (BMT), with a phosphodiesterase 5 inhibitor (PDE5i) for erectile dysfunction (ED) treatment.

The study targets patients who have not responded to PDE5i monotherapy.

Palatin anticipates topline data from the Phase II trial by the end of 2024.

The trial aims to enrol around 50 participants for an open-label, dose-escalation study. It will focus on men with ED.

The study, which has received clearance from the Food and Drug Administration (FDA) and approval from an Institutional Review Board (IRB), is being carried out under an investigator-sponsored Investigational New Drug (IND).

Its primary goal is to evaluate the safety and efficacy of BMT when used in conjunction with a PDE5i.

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Palatin’s previous clinical studies on BMT, both as a stand-alone treatment and in combination with a PDE5i, have shown significant improvements in erectile function.

Palatin president and CEO Carl Spana said: “Approximately 30–40% of ED patients exhibit little or no response to PDE5i monotherapy, such as Viagra, Cialis and Levitra.

“These PDE5i monotherapy drugs account for over $4bn of annual sales, yet PDE5i monotherapy does not work for a significant portion of ED patients. This represents a substantial unmet medical need for more effective ED treatments.

“Based on our clinical data and mechanisms of action research, we believe that BMT combined with a PDE5i is synergistic and will be a clinically meaningful ED treatment for non-responders to current PDE5i monotherapy.”

The company has also developed a new single-injection co-formulation of bremelanotide and a PDE5i.

It plans to file an IND application for this new co-formulation later this year.

A potential Phase III clinical trial for ED patients unresponsive to PDE5i monotherapy is expected to begin in the first half of 2025.

Last week, Palatin started a Phase II clinical trial of breatelanotide, a melanocortin 4 receptor (MC4R) agonist, to treat obesity.