Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has given the green light to commence an additional clinical study for QRX003, a topical lotion developed for the treatment of Netherton Syndrome (NS).
The study, led by Dr. Amy Paller from Northwestern (NASDAQ:NWE) University, is set to enroll up to eight subjects who will apply QRX003 over more than 80% of their body surface area twice daily for a 12-week period.
This new study is significant as it marks the most extensive application of QRX003 in a clinical setting to date, mimicking the real-world use of the product by NS patients if it receives regulatory approval. The data from this study is expected to augment the existing data to support a potential future New Drug Application (NDA) submission for QRX003.
Netherton Syndrome is a rare and severe genetic disorder characterized by chronic skin inflammation and scaling. QRX003 contains a broad-spectrum serine protease inhibitor targeting kallikreins, enzymes linked to the excessive skin shedding associated with NS.
Quoin's ongoing clinical trials have so far applied QRX003 to approximately 20% of the participants' body surface area, mainly on the arms and lower legs. The expansion of the application area in the new study is designed to provide comprehensive data on the safety and efficacy of the treatment when used as intended for NS patients.
The company's forward-looking statements caution that actual results and the timing of events could differ materially from those anticipated due to various risks and uncertainties. These include potential delays in clinical studies, the need for additional funding, and the possibility that the studies may not yield sufficiently robust data to support an NDA filing.
Quoin Pharmaceuticals emphasizes that its focus remains on addressing the unmet medical needs of rare and orphan diseases. The information regarding the new study and the FDA clearance is based on a press release statement.
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