Palatin Announces Initiation of Pivotal Phase 3 PL9643 MELODY-1 Clinical Trial in Patients with Dry Eye Disease

Top-Line Results Currently Expected Second Half Calendar 2022

CRANBURY, NJ, USA I December 28, 2021 I Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced the initiation of the pivotal Phase 3 MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is designed to enroll up to 400 patients at multiple U.S. sites, and top-line results are currently expected second half calendar 2022.

"We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease," said Carl Spana, Ph.D., CEO and President of Palatin. "This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin's expertise and efficiency in melanocortin peptide development for indications with unmet medical need."

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 subjects with dry eye disease (DED). The study design is based on positive Phase 2 results of PL9643 for the treatment of dry eye disease, and an end-of-phase 2 (EOP2) meeting with the with the U.S. Food and Drug Administration (FDA), reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, to support a New Drug Application (NDA) filing, a second phase 3 study (MELODY-2) and long-term safety study (MELODY-3) will be required. If the program progresses as planned, top-line results from MELODY-1 would be available second half calendar 2022, MELODY-2 data read out second half calendar 2023, with a potential NDA submission first half calendar 2024.

"Progressing PL9643 into Phase 3 is a significant milestone for the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of Palatin. "PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease."

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. Dry eye disease 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 the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires week or months to demonstrate activity.

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, MC1r through MC5r. 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 and natriuretic peptide 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. For additional information regarding Palatin, please visit Palatin's website at www.palatin.com and follow Palatin on Twitter at @PalatinTech. 

SOURCE: Palatin Technologies

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