Palatin Technologies, Inc. Announces Positive End-Of-Phase 2 Meeting with FDA on PL9643 for the Treatment of Dry Eye Disease
June 29, 2021 at 07:30 am EDT
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Palatin Technologies, Inc. announced the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for PL9643 for the treatment of dry eye disease (DED). The EOP2 meeting scope included all aspects of PL9643's development plan, with the FDA and Palatin reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, a potential second Phase 3 study and long-term safety study were discussed to support a New Drug Application (NDA). Palatin remains on track to initiate the Phase 3 program in DED patients during the fourth quarter of calendar year 2021, with data readout expected in the second half of calendar year 2022. If the program progresses as planned, an NDA submission is targeted for the second half of calendar year 2023. PL9643 is a novel melanocortin agonist, delivered to the eye topically via eyedrops. Palatin previously announced positive results in its Phase 2 study of PL9643 for the treatment of DED. Statistically significant improvement in multiple signs and symptoms was achieved in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability.
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. 
