Palatin announces results of Melody-1 phase 3 trial for treatment of dry eye disease

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Palatin has announced results from its Melody-1 pivotal Phase 3 clinical trial of PL9643 for the treatment of dry eye disease (DED).

The trial was a multi-center, double-masked, randomized, vehicle-controlled study, and had two co-primary endpoints. The co-primary endpoints were ocular discomfort as well as conjunctival lissamine green staining. There was multiple other symptom and sign secondary endpoints of DED as well according to the company.

Intent-to-Treat (ITT) analysis was also adjusted for age and gender since 60% of the total subjects were over age 60, and 68% of the total subjects were female.

According to the company, PL9643 treatment demonstrated clinically meaningful and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints not named by the company.

However, while the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population, they did not achieve statistical significance. In the unadjusted, planned analysis the co-primary endpoints and secondary endpoints did not reach statistical significance.

Carl Spana, PhD, President and CEO of Palatin discussed the results in a press release and stated that even though the results did not meet statistical significance, the company will move forward with PL9643.

“We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign endpoints. It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom. While additional analyses are ongoing, the initial results reinforce the potential of PL9643 as a treatment to address both symptoms and signs of DED,” said Spana. “Our comprehensive data analysis is ongoing, and upon completion, we plan to meet with the FDA to discuss and get feedback on the design of the next pivotal Phase 3 clinical trial. Furthermore, we will continue with our efforts for a collaboration partner for our DED program.”

Safety analysis showed PL9643 was well-tolerated with fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287).

References:

1. Palatin Announces Results of PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED). Press release. Accessed February 29, 2024. Published February 28, 2024. https://palatin.com/press_releases/palatin-announces-results-of-pl9643-melody-1-pivotal-phase-3-clinical-trial-in-patients-with-dry-eye-disease-ded/

2. Clinicaltrials.gov. A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye (MELODY-1). NCT05201170. Accessed February 29, 2024.