Palatin Technologies Announces FDA Orphan Drug Designation for PL-8177 to Treat Non-Infectious Uveitis

VCBeat (WeChat ID: vcbeat) has learned from foreign media that biopharmaceutical company Palatin Technologies recently announced that its new drug, PL-8177, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of non-infectious anterior, intermediate, and posterior uveitis. Non-infectious uveitis comprises a group of inflammatory diseases that can cause swelling of ocular tissues and damage them, leading to vision loss in patients.

Palatin Technologies, founded in 1986, is a biopharmaceutical company based in Cranbury, New Jersey, USA. The company focuses on developing receptor-specific peptide therapies targeting unmet medical needs.

Palatin Technologies develops drug candidates for the treatment of female sexual dysfunction, male erectile dysfunction, cardiovascular diseases, and inflammation, based on the principle of modulating the molecular activity of melanocortin and natriuretic peptide receptors. Among these, bremelanotide, a candidate drug for treating female sexual dysfunction, has received FDA approval for market launch.

Non-infectious uveitis is characterized by swelling or damage to ocular tissues, resulting not from an active infection but from an intraocular inflammatory response. Based on its location within the eye, uveitis is classified as anterior, intermediate, or posterior. Patients with initial onset of non-infectious uveitis may experience symptoms such as blurred vision, eye pain, photophobia, and dark floaters in their visual field. If left untreated, uveitis can lead to vision loss.

Melanocortin receptor 1 (MC1R) plays a critical role in anti-inflammatory responses and immune regulation. PL-8177, which has recently received orphan drug designation, is a selective melanocortin receptor 1 (MC1R) agonist peptide with a structure consisting of a synthetic cyclic heptapeptide. The drug has been evaluated in animal models of experimental autoimmune uveitis, confirming its efficacy in reducing inflammation and restoring normal retinal architecture. Currently, Palatin Technologies is developing an oral formulation of PL-8177 for the treatment of ulcerative colitis and other inflammatory bowel diseases, as well as a subcutaneous injection formulation for the treatment of non-infectious uveitis.

Palatin Technologies’ New Drug Receives FDA Orphan Drug DesignationPalatin Technologies’ new drug has received orphan drug designation from the U.S. Food and Drug Administration (FDA), meaning that the company will not only receive R&D support during clinical development but also benefit from reduced or waived certain FDA fees, as well as enjoy seven years of marketing exclusivity. In response, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies, stated, “We are delighted to receive the first orphan drug designation from the FDA for our melanocortin receptor agonist peptide (PL-8177). Unlike corticosteroids, immunosuppressants, and biologics targeting specific cytokines or receptors, melanocortin receptor 1 peptides can address chronic inflammation and restore normal immune function. We look forward to advancing the clinical treatment of non-infectious uveitis, a condition with limited therapeutic options, using PL-8177.”

Palatin Technologies disclosed that it would submit an Investigational New Drug (IND) application for non-infectious uveitis to the FDA in the third quarter of 2019, with plans to conduct Phase II clinical trials in the first half of 2020.

(Compiled by: Wang Chan)