The study examines the effectiveness of PL9643 for the treatment of patients with dry eye disease.
Palatin Technologies has completed enrollment in the Phase 3, MELODY-1 study of PL9643 for the treatment of patients with dry eye disease (DED).
According to a press release from Palatin, the trial enrollment has been completed with 570 patients enrolled with topline results on track to be released by the end of the fourth quarter of 2023.1 Assuming positive results, the remaining Phase 3 studies are expected to be completed by the end of calendar year 2024 and early calendar year 2025, with a New Drug Application submission to the US Food and Drug Administration (FDA) for approval mid-2025 according to Palatin.1
The company previously released positive interim analysis data and presented at the ARVO 2023 conference.
Carl Spana, PhD, President and CEO of Palatin, discussed the trial in the press release.
“We are committed to addressing unmet needs of DED patients. We believe that PL9643, with its novel mechanism of action and differentiated product profile for efficacy, safety and ocular tolerability, if approved, will be a first-in-class treatment option for the millions of patients who suffer from DED,” said Spana. “We are optimistic about results of the Phase 3 PL9643 data based on the positive interim analysis and are pleased to have completed enrollment so promptly. I thank the patients, investigators, clinical site staff, and our employees for achieving this important milestone.”
The Phase 3 MELODY-1 clinical study is being conducted in the US, and is a “multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints.”1
The study design is based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program, according to Palatin.1
Palatin described the melanocortin receptor (“MCr”) as a system that has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. Many tissues and immune cells located throughout the body, including the gut, kidney and eye, express melanocortin receptors which, according to the company, allows them to directly activate natural pathways to resolve disease inflammation.1