Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study

Core Viewpoint - Quoin Pharmaceuticals has received FDA clearance to initiate a second pivotal clinical study for QRX003, targeting Netherton Syndrome, which is expected to generate comprehensive safety and efficacy data to support regulatory approval [1][3]. Group 1: Clinical Study Details - The new study, CL-QRX003-002, will involve approximately 12-15 subjects and will apply QRX003 to at least 80% of each subject's body surface area, enhancing the data collected compared to earlier studies [2][5]. - This pivotal study complements another ongoing study, CL-QRX003-003, where QRX003 is administered as monotherapy without off-label systemic therapy [2][5]. - Quoin anticipates recruiting between 24-30 subjects across 6 U.S. sites and up to 6 international sites, with recruitment expected to be completed by the end of Q1 2026 [2][5]. Group 2: Product and Market Potential - QRX003 is a topical lotion designed to downregulate the hyperactivity of kallikreins in the skin, addressing excessive skin shedding and associated symptoms in Netherton Syndrome patients [1][3]. - The combined data from both pivotal studies is expected to provide QRX003 with a broad label opportunity post-approval, allowing it to be used both as a monotherapy and in conjunction with off-label systemic treatments [5]. Group 3: Company Overview - Quoin Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes products targeting various conditions such as Peeling Skin Syndrome and Epidermolysis Bullosa [4]. - The company is committed to addressing unmet medical needs for patients and their communities [4].