On Friday, H.C. Wainwright maintained its Buy rating and $17.00 price target for Palatin Technologies (NYSE:PTN) stock, following the company's announcement on Thursday regarding the commencement of a Phase 2 clinical trial.
This trial is focused on the co-administration of bremelanotide, an FDA-approved melanocortin 4 receptor agonist, with a phosphodiesterase 5 inhibitor (PDE5i) for the treatment of erectile dysfunction (ED).
The study aims to enroll approximately 50 patients in an open-label, dose escalation format to assess the safety and efficacy of this combination therapy. Expectations are set for topline data to become available by the end of 2024.
Palatin has also been developing a new co-formulation that combines bremelanotide with a PDE5i, which can be administered through a single injection. The company plans to submit an Investigational New Drug (IND) application for this product to the FDA later in the year. The potential Phase 3 clinical trial for this novel formulation is projected to begin in the first half of 2025, targeting ED patients who have not had success with PDE5i monotherapy.
The innovative approach taken by Palatin seeks to offer a solution for ED patients who do not respond to the primary PDE5 inhibitors, such as Viagra, Cialis, and Levitra. Currently, the treatment options for these patients are quite limited and include invasive methods like penile injections, urethral suppositories, surgical implants, and various devices.
Erectile dysfunction represents a significant market opportunity, characterized by a considerable number of patients with unmet medical needs, especially those unresponsive to standard PDE5 inhibitor treatments.
Palatin's extensive experience in the clinical, regulatory, and commercialization aspects of sexual dysfunction treatments is expected to be a strong foundation for the company as it ventures into this new phase of clinical development in ED therapies.
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