Palatin Gets Orphan Drug Designation For Melanocortin Agonist Peptide From FDA

(RTTNews) - Palatin Technologies Inc. (PTN) said Thursday that the U.S. Food and Drug Administration granted orphan drug designation for PL-8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. PL-8177 is a Melanocortin Receptor 1 Agonist.

Non-infectious uveitis is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss.

"We are very pleased to receive our first orphan drug designation for a melanocortin agonist peptide from the FDA," said Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies.

Palatin said it plans to file an IND application for non-infectious uveitis with the FDA in the third quarter of calendar year 2019, and initiate a Phase 2 clinical study in the first half of calendar year 2020.

In both animal studies and Phase 1 subcutaneous studies with PL-8177 no safety or tolerability concerns were reported.