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Palatin Announces Database Lock for PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED) | ||
By: PR Newswire Association LLC. - 05 Feb 2024 | Back to overview list |
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Top-Line Results Expected in February CRANBURY, N.J., Feb. 5, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced database lock for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED). MELODY-1 has two co-primary efficacy endpoints: one clinical sign of DED and one clinical symptom of DED. If one or both co-primary end points are met, the study will be deemed a success and the secondary end points will be evaluated using a hierarchical testing strategy. "We are excited by the database lock and that data analysis by the independent statisticians has commenced. We look forward to reporting top-line results from the PL9643 MELODY-1 pivotal Phase 3 clinical trial later in February," said Carl Spana, Ph.D., President and CEO of Palatin. "I want to thank our clinical team, our study sites and our independent service firms for their dedication and collaborative efforts." The pivotal Phase 3 MELODY-1 trial is a multi-center, randomized, double–masked and vehicle–controlled study, that enrolled 575 patients at sites in the U.S. The trial evaluated 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, after treatment for 12 weeks. The study design was 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. The remainder of the Phase 3 program, which includes the Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024. About Dry Eye Disease (DED) About Melanocortin Receptor Agonists and Inflammation Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Forward-looking Statements Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-announces-database-lock-for-pl9643-melody-1-pivotal-phase-3-clinical-trial-in-patients-with-dry-eye-disease-ded-302052721.html SOURCE Palatin Technologies, Inc. |
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