Quoin Pharmaceuticals Files Peeling Skin Syndrome IND for QRX003, Plans Phase 2 in H2 2026
QNRX•Quoin submitted an IND for QRX003 to treat Peeling Skin Syndrome, a disease with no approved therapy, aiming to start a Phase 2 trial with 6–8 patients in H2 2026. Initial pediatric data report over 15 months of treatment with significant skin and quality-of-life improvements and no adverse events.
1. IND Submission for Peeling Skin Syndrome
Quoin Pharmaceuticals filed its first IND application for QRX003 to treat Peeling Skin Syndrome (PSS), a rare genodermatosis with no approved treatments. The submission marks the second indication for QRX003 following a prior IND in Netherton Syndrome, underscoring the platform’s versatility in rare dermatologic diseases.
2. Supporting Clinical Data
The IND is supported by an investigator-led pediatric study in which the initial subject received QRX003 for over 15 months, experiencing significant improvements in skin integrity, sleep patterns and overall quality of life. No adverse events were reported during the treatment period, highlighting a favorable safety profile.
3. Phase 2 Trial Design
Pending FDA clearance, Quoin expects to initiate a Phase 2 study in the second half of 2026, recruiting 6–8 pediatric and adult patients across the US and Europe. The trial will evaluate efficacy endpoints related to skin shedding reduction, symptom relief and quality-of-life measures in PSS.
4. Pipeline Expansion and Future Outlook
QRX003’s advancement into a second rare disease indication joins QRX009, a topical rapamycin candidate slated for clinical testing later this year. Quoin aims to build a robust pipeline targeting multiple orphan dermatologic diseases, potentially enhancing its commercial outlook in the rare disease market.
