Orphan Designation for Non-Infectious Uveitis Drug Candidate

Phase 2 Trial To Begin in 2020

Palatin Technologies, Inc. has been granted an orphan drug designation for PL-8177 for the treatment of non-infectious intermediate, posterior, pan, and chronic anterior uveitis. Non-infectious uveitis produces swelling, destroys eye tissue, and can result in vision loss.

Non-infectious uveitis is caused by inflammatory responses inside the eye and can arise from autoimmune responses, responses to infections or tumors in the eye or other parts of the body, physical injury, or toxins. Initial symptoms include blurred vision, eye pain, dark floating spots in vision, and light sensitivity. If left untreated, uveitis can cause vision loss or blindness.

Palatin has conducted a phase 1 study with PL-8177, a melanocortin receptor 1 agonist (MCR1), under an investigational new drug (IND) application for ulcerative colitis. The company plans to file an IND application for non-infectious uveitis in the third quarter of 2019, and initiate a phase 2 clinical trial in the first half of 2020. Animal studies and phase 1 subcutaneous studies have reported no safety or tolerability concerns with PL-8177.

PL-8177 has been evaluated in animal models of experimental autoimmune uveitis, a model with certain clinical features of human uveitis. In these studies, the agent showed a reduction of inflammation and restoration of normal retinal structure.

Other current research includes an oral formulation of PL-8177 for treating ulcerative colitis and other inflammatory bowel diseases, as well as a subcutaneous injection formulation for non-infectious uveitis.

Source: PR Newswire, June 6, 2019