Palatin Locks Database for Phase 3 DED Trial of PL9643 MELODY-1

Palatin Technologies, a biopharmaceutical firm, has reached a significant milestone in its Phase 3 clinical trial for PL9643, a potential treatment for dry eye disease (DED). The company has locked its database for the MELODY-1 trial, which is currently undergoing data analysis by independent statisticians. The results are expected to be announced in February.

The MELODY-1 trial is designed to assess the safety and effectiveness of PL9643 compared to a placebo. It features two primary endpoints related to clinical signs and symptoms of DED. Success in meeting these endpoints will trigger an evaluation of secondary outcomes using a hierarchical strategy. The trial, which is double-masked and vehicle-controlled, enrolled 575 participants across multiple U.S. sites. It focuses on patients with moderate-to-severe DED and evaluates the melanocortin agonist PL9643 ophthalmic solution over a 12-week period.

Palatin's President and CEO, Carl Spana, expressed gratitude to the clinical team and collaborators for their efforts. He highlighted the importance of the database lock and the commencement of data analysis, indicating the company's anticipation for the results.

Dry eye disease is a prevalent condition affecting over 20 million people in the United States. It is characterized by insufficient eye moisture, leading to discomfort, pain, and potentially permanent vision damage if left untreated. Current treatments are often considered inadequate and can take a long time to show effects.

The melanocortin receptor system, which Palatin's PL9643 targets, plays a role in inflammation and immune responses among other functions. The modulation of these receptors can have significant therapeutic effects. The melanocortin agonist is believed to activate natural pathways to reduce inflammation associated with DED.

Palatin is dedicated to developing novel medicines that address significant unmet medical needs. The company aims to create receptor-specific products and collaborate with industry leaders to maximize their market potential.

The Phase 3 program for PL9643 also includes the MELODY-2 and MELODY-3 studies, which are expected to begin enrolling patients in the latter half of 2024. Palatin's strategy involves developing innovative products and establishing partnerships to ensure their successful commercialization.

Dry Eye Disease and its Impact:
Dry eye disease is an inflammatory condition that, if not addressed, can result in severe pain and irreversible damage to the eye's cornea and vision. It impacts the eye's surface, causing symptoms such as irritation, redness, and blurred vision. The condition is marked by a lack of adequate moisture and lubrication, which can lead to inflammation, discomfort, and a decrease in quality of life. In severe cases, it can result in permanent vision impairment.

Melanocortin Receptor Agonists and Their Role in Inflammation:
The melanocortin receptor system is involved in various bodily functions, including inflammation, immune responses, metabolism, and more. There are five types of these receptors, and their modulation through specific agonists or antagonists can lead to significant pharmacological effects. Many tissues and immune cells in the eye, as well as other parts of the body like the gut and kidney, express melanocortin receptors, offering a direct approach to managing inflammatory diseases.

About Palatin Technologies:
Palatin Technologies is a biopharmaceutical company that specializes in developing first-in-class medicines that modulate the melanocortin receptor system. The company focuses on creating targeted product candidates for diseases with significant medical needs and commercial opportunities. Palatin's approach includes developing innovative products and partnering with industry leaders to optimize their commercial reach.