Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced the results of a planned interim analysis of the Phase 3 pivotal study of PL9643 (MELODY-1) in patients with dry eye disease (DED). The interim analysis included an assessment and review by the independent Data Monitoring Committee (DMC) of the efficacy and safety of the first 120 patients who had completed treatment. Based on their review, the DMC recommended the study continue with a study sample size target of up to 350 patients. No safety concerns were identified by the DMC.
The DMC’s primary objective was to provide a recommendation on the final sample size based on an interim assessment using a conditional power modeling approach. The DMC had the option to recommend a final sample size of up to 600 patients. The DMC performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients. Topline results are expected in the second quarter of calendar 2023.
“We are highly encouraged by the DMC’s recommendation to continue enrolling patients in this ongoing trial. The emerging data, including the safety and ocular tolerability, indicate that PL9643 could be a potentially safe and effective treatment for patients with DED,” said Carl Spana, Ph.D., President and CEO of Palatin. “Based on trial results to date, we believe PL9643, with its differentiating factors, could provide a fast-acting and well-tolerated treatment option for the millions of patients suffering from DED, and we look forward to presenting topline results of this Phase 3 trial in the second quarter of calendar 2023.”
The pivotal Phase 3 MELODY-1 clinical study 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. The study design is based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), reaching agreement on all key elements of a pivotal Phase 3 clinical program.
