QRX003 - (CL-QRX003-004)

Aug. 28, 2026: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) reported positive interim results from CL-QRX003-004, an ongoing Phase 2/3 open-label study of QRX003 4% lotion in Netherton Syndrome.

In the first six patients completing 12 weeks, the primary endpoint was met with statistical significance: 4/6 patients (66.7%; 95% CI 22.28%-95.67%) achieved at least a 1-grade improvement in Investigator Global Assessment at week 12 (p=0.0087 vs pre-specified alpha 0.0215). Two of the four responders achieved at least a 2-grade improvement.

A key secondary endpoint, Global Impression of Change, also met statistical significance, with mean change of -1.5 (SD 0.82; 95% CI -2.3 to -0.6; p=0.0070 vs alpha 0.0215). All three patients with moderate-to-severe baseline pruritus achieved at least a 3-grade improvement on WI-NRS after 12 weeks; one improved by more than 6 grades. IASI severity improved 31%-87% in four of six patients.

No treatment-related serious adverse events, deaths, or clinically significant ECG, laboratory, or vital sign abnormalities were reported.

Quoin said it expects to complete enrollment of approximately 20 evaluable patients by the end of 2026 and report topline data in 2Q 2027. The release also mentions a potential NDA filing in 2027.