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
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
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)
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ('MCr') system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MCR1 through MCR5. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
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
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential.
Contact:
Email: info@palatin.com
Email: investors@palatin.com
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