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Quoin Pharmaceuticals Reports Positive Interim Data from Ongoing Phase 2/3 Study of QRX003 in Netherton Syndrome

QNRX
  • Quoin Pharmaceuticals announced positive interim results from the CL-QRX003-004 Phase 2/3 study of QRX003 4% lotion for Netherton Syndrome.
  • The primary endpoint of 1-grade or greater improvement in Investigator Global Assessment (IGA) met statistical significance (p=0.0087 vs. alpha 0.0215).
  • Four of the first six participants (66.7%) achieved the target IGA improvement after 12 weeks of treatment.
  • Two participants achieved a 2-grade or greater IGA improvement.
  • The key secondary endpoint, Global Impression of Change, achieved statistical significance (p=0.0070 vs. alpha 0.0215) with a mean change of -1.5.
  • All three participants with moderate-to-severe pruritus at baseline achieved a clinically meaningful 3-grade or greater improvement in the Worst Itch Numeric Rating Scale.
  • One participant with pruritus achieved a greater than 6-grade improvement in itch severity.
  • IASI scores showed 31% to 87% reduction in severity for four participants who also met the primary IGA endpoint.
  • No treatment-related serious adverse events or clinically significant safety abnormalities were recorded.
  • The study cohort included six participants aged 11 to 52 years, all of whom discontinued other standard of care therapies.
  • Quoin expects to complete recruitment of all 20 participants by the end of 2026.
  • Topline data for the full study is scheduled for reporting in the second quarter of 2027.
  • QRX003 holds Orphan Drug, Rare Pediatric Disease, & Fast Track designations from the FDA for Netherton Syndrome.
  • If approved, QRX003 could become the first FDA-approved treatment specifically for Netherton Syndrome.