Quoin Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Netherton Syndrome

Core Viewpoint - Quoin Pharmaceuticals has received Orphan Drug Designation in Europe for its lead product QRX003, which is in late-stage clinical trials for treating Netherton Syndrome, providing the company with significant regulatory advantages and potential market exclusivity [1][2][3] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes four products targeting various conditions [4] Product Development - QRX003 is designed as a topical, non-systemic treatment for Netherton Syndrome, a severe disease with no current approved therapies, and is currently undergoing multiple late-stage clinical trials [3][4] - The product has shown promising clinical results, including significant skin healing and reduction of severe chronic pruritus in pediatric studies, indicating its potential efficacy as a broad-spectrum kallikrein inhibitor [3] Regulatory Milestones - The Orphan Drug Designation provides Quoin with benefits such as scientific advice on study protocols, fee reductions, and access to EU grants, and if approved, QRX003 will receive 10 years of market exclusivity in Europe [2][3]