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

Palatin Technologies, Inc. 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.

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“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.”

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