Palatin Technologies, Inc. Announces Initiation of Pivotal Phase 3 Pl9643 Melody-1 Clinical Trial in Patients with Dry Eye Disease
December 28, 2021 at 07:30 am EST
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Palatin Technologies, Inc. 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. 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.
Palatin Technologies, Inc. is a biopharmaceutical company. The Company is engaged in developing 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 unmet medical need and commercial potential. Its new product development activities focus primarily on MC1r agonists, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease. It is also engaged developing peptides that are active at more than one melanocortin receptor, and MC4r peptide and small molecule agonists with potential utility in obesity and metabolic-related disorders, including rare disease and orphan indications. It has completed Phase III PL9643 clinical study for dry eye disease. It is also conducting Phase II study of oral PL8177 in patients with ulcerative colitis.
PALATIN TECHNOLOGIES, INC. 
