Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments. QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body clinical trials designed to assess safety and efficacy in patients with Netherton Syndrome. QRX003 previously received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA) for the treatment of Netherton Syndrome, providing potential benefits including market exclusivity upon approval, tax credits for clinical testing, and certain regulatory fee reductions.

QRX003 has also been granted Pediatric Rare Disease Designation by the FDA. Netherton Syndrome is a rare, inherited skin disorder caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections and allergic complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment in quality of life.

There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited to supportive care and off-label therapies. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.