Quoin Pharmaceuticals (NASDAQ: QNRX) has announced positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome (NS), a rare, genetic skin disease.
According to Quoin, an interim analysis of the first six patients to complete 12 weeks of treatment met a pre-specified alpha-adjusted target for the primary endpoint, demonstrating a statistically significant improvement of at least one grade in Investigator’s Global Assessment across the entire treatment area.
In a statement, Dr. Michael Myers, CEO and co-founder of Quoin, commented, “These interim results provide further objective evidence that QRX003 has the potential to change the course of Netherton Syndrome. Four of the first six participants achieved a statistically significant improvement in the primary endpoint and in a key secondary endpoint after 12 weeks of treatment with QRX003 vs pre-specified alpha adjustment. Importantly, this was accomplished after participants had stopped every other topical and systemic therapy they were using. The same four participants who met the primary endpoint achieved clinically significant improved IASI scores underscoring the robustness and consistency of the results across two objective clinician assessments.”
Dr. Myers added, “In addition, for the three participants who had the highest and most severe pruritus or itch at baseline, a highly clinically meaningful 3-grade or greater improvement was achieved after treatment with QRX003, including a greater than 6 grade improvement for one participant. Finally, these results match those previously reported from our ongoing pediatric compassionate use program as we continue to assemble a broad body of clinical evidence regarding the potential efficacy of QRX003 as treatment for this disease. We look forward to completing recruitment into this study by the end of the year and reporting the full data set in 2Q next year.”
