Quoin Pharmaceuticals, Ltd. (QNRX), a late clinical-stage pharmaceutical company, announced that it has received the orphan drug designation for QRX003 from Japan's Ministry of Health, Labour and Welfare, or MHLW, for the treatment of a rare and severe genetic skin disorder, Netherton Syndrome.
Netherton syndrome is a rare inherited skin disorder caused by the mutation of the SPINK5 gene. This results in severe skin barrier dysfunction leading to chronic inflammation and high-risk allergic complications. There is currently no approved treatment for this disease.
Under this designation, the company receives regulatory and development incentives in Japan, including up to 10 years of market exclusivity upon approval, the company noted.
Apart from the orphan drug designation for Netherton syndrome, QRX003 has pediatric rare disease designation and fast track designation from the U.S. Food and Drug Administration, or FDA, and also orphan drug designation from the European Medicines Agency, or EMA.
Additionally, Quoin has applied to the Saudi Food and Drug Authority for Breakthrough Medicine Designation for QRX003.
Currently, QRX003 lotion (4%) is being evaluated in a phase 2 whole-body trial for patients with Netherton syndrome. The company's Phase 3 study is expected to begin in the second half of 2026, with an NDA filing anticipated in 2027.
Quoin is closely collaborating with lead Japanese clinicians in order to refine the clinical and regulatory pathway of QRX003 in treating Netherton patients, the firm noted.
"Japan is a strategically important market for QRX003, and, along with the US and Western Europe, we plan to self-commercialize QRX003 and our other pipeline products once approved. This designation is another important step in that strategy and complements the regulatory recognition QRX003 has received in the United States and Europe," commented Michael Myers, CEO of Quoin Pharmaceuticals.
Quoin has traded between $4.11 and $41.8 over the last year. Quoin shares closed Thursday at $4.29, down 3.16%. In the pre-market, shares are trading at $4.33, up 0.93%.
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