USFDAJun 2, 2026, 08:32 AM
Quoin Pharma Submits First-Ever IND for Peeling Skin Syndrome Treatment
AI Summary
Quoin Pharmaceuticals announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for QRX003 to treat Peeling Skin Syndrome (PSS), marking the first-ever IND for this disease. The company plans to initiate a Phase 2 clinical study in the second half of 2026, pending FDA review. This submission is supported by positive initial clinical data from an investigator-led pediatric study, where QRX003 showed significant improvements in skin, sleep, and quality of life over 15 months with no adverse events. This is the second indication for QRX003, in addition to Netherton Syndrome, highlighting its versatility.
Key Highlights
- IND application submitted to FDA for QRX003 for Peeling Skin Syndrome (PSS).
- First-ever IND submission for the treatment of Peeling Skin Syndrome.
- Phase 2 clinical study for PSS expected to initiate in 2H 2026.
- Initial subject treated with QRX003 for over 15 months showed significant clinical improvements.
- QRX003 was well tolerated with no adverse events reported in the ongoing study.
- Phase 2 study to recruit 6-8 pediatric and adult PSS patients in US and Europe.
- QRX003 is now advancing toward formal clinical development in a second rare disease indication.
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