Benzinga | Jun 29, 2021 07:31AM EDT

Palatin Announces Completion Of End-Of-Phase 2 Meeting With FDA On PL9643 For Dry Eye Disease; Co. And FDA Reached Agreement On All Ket Elements Of Phase 3 Program

Palatin Technologies, Inc. ("Palatin") (NYSE:PTN) a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, today 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.

"As a practicing ophthalmologist, I am encouraged by the data to date on the PL9643 program, which offers much needed optimism for an effective treatment of dry eye without tolerability issues," said Michael Raizman, M.D., Chief Medical Officer of Palatin. "I look forward to further demonstrations of PL9643's potential to transform the topical treatment of DED for the millions of people suffering from the disease."

"We now have clarity on the registrational path required to demonstrate the safety and efficacy of PL9643, having reached agreement with FDA on all key elements of PL9643's pivotal phase 3 program for DED," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "This is an important corporate milestone, as we now have a second melanocortin agonist in phase 3 development, which we believe validates our strategy which focuses our efforts on the development of melanocortin based therapeutics for inflammatory and autoimmune conditions."

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.