Quoin Pharmaceuticals Ltd. (QNRX), a clinical-stage pharma firm specializing in rare diseases, has received FDA clearance to begin a second pivotal clinical trial, CL-QRX003-002, for its lead product QRX003, a topical treatment for Netherton Syndrome or NS.
The lotion, formulated with a broad-spectrum serine protease inhibitor, has shown promising results in reducing excessive skin shedding by targeting overactive kallikreins. Data from ongoing studies revealed rapid and nearly complete skin healing, along with elimination of severe itching and sleep disturbances following twice-daily application.
The new study builds on encouraging results from an earlier open-label trial where QRX003 was applied to 20 percent of patients' skin. In this next phase, the product will be used twice daily on 80 percent of the body surface area in 12-15 subjects, who will continue existing off-label systemic treatments. This setup is designed to yield more robust safety and efficacy data reflective of real-world use.
CL-QRX003-002 will run alongside a complementary pivotal trial, CL-QRX003-003, led by Dr. Amy Paller at Northwestern University, in which QRX003 is administered as monotherapy without systemic treatments. Together, both studies aim to recruit 24-30 participants across six U.S. and up to six international sites, with most U.S. sites already open and international sites nearing readiness. Quoin expects to complete recruitment by Q1 2026 and aims to submit a New Drug Application later that year.
CEO Dr. Michael Myers stated that this FDA clearance marks a major milestone for Quoin. He emphasized that the company is now uniquely positioned as the only one running two late-stage, full-body pivotal trials for Netherton Syndrome. Myers noted that the combined data from both studies could form a strong foundation for regulatory approval of QRX003.
QNRX is currently trading at $8.66, or 3.38% higher on the Nasdaq Capital Market.
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