JUN 07, 2019
The FDA has granted orphan drug designation to a synthetic peptide for the treatment of noninfectious intermediate, posterior, chronic anterior and panuveitis.
Designed by Palatin Technologies, PL-8177 is a melanocortin agonist peptide that is delivered via a subcutaneous injection. A growing number of studies suggest that melanocortin receptors play an important role in anti-inflammatory responses and immunoregulation.
"Unlike corticosteroids, immunosuppressive agents, and biological therapies targeting specific cytokines or receptors, melanocortin receptor 1 peptides work to resolve chronic inflammations and restore normal immune function,” explained the company’s president and CEO, Carl Spana, PhD.
In preclinical studies of autoimmune uveitis, PL-8177 was shown to reduce inflammation and restore normal retinal structure in mice. Phase 2 trials are expected to begin in 2020; so far, phase 1 trials have reported no safety or tolerability concerns. The novel drug is also in early-stage trials for ulcerative colitis.
Palatin plans to file an investigational new drug application for noninfectious uveitis later this year.