Biopharmaceutical company Palatin Technologies Inc (NYSE American:PTN) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) orphan drug designation for PL-8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis.
Non-infectious uveitis is a group of inflammatory diseases that produce swelling and destroy eye tissue and can result in vision loss.
According to the company, PL-8177 is a selective MC1r (melanocortin receptor 1) agonist peptide and a synthetic cyclic heptapeptide with demonstrated efficacy in animal experimental autoimmune uveitis disease models. PL-8177 is a potent agonist at human MC1r, with sub-nanomolar affinity binding and EC50 functional values.
The company has launched a single and multiple ascending-dose Phase 1 study with PL-8177 under an investigational new drug (IND) application for ulcerative colitis. It plans to file an IND application for non-infectious uveitis with the FDA in the third quarter of calendar year 2019 as well as 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. PL-8177 has been evaluated in animal models of experimental autoimmune uveitis, a model presenting certain clinical features of human uveitis, the company said.
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