Quoin Pharmaceuticals Ltd. announced that it has received comprehensive and constructive Scientific Advice from the European Medicines Agency for the clinical and regulatory development of QRX003 in Europe, as a potential treatment for Netherton Syndrome. This Scientific Advice was received in response to a Briefing Submission document filed by Quoin to the EMA on May 26, 2022. Based on standard review periods for such submissions, which may also include an in-person meeting with the EMA, Quoin had anticipated receiving feedback from the EMA in mid-September.

Instead, the EMA truncated the standard review period and provided this Scientific Advice to Quoin without the requirement for an in-person meeting. QRX003 is currently in clinical testing in the US in a randomized, double blinded, vehicle-controlled study that is being conducted under an open U.S. Investigational New Drug (IND) Application which will assess two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials will be applied once daily over a twelve-week period, to pre-designated areas of the patient's body.

Based on discussions with the U.S. Food and Drug Administration (FDA), a number of different clinical endpoints will be assessed in the study. The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients.

In conjunction with the company's strategy of self-commercializing its portfolio of products in the U.S. and Europe, Quoin has established a global network of marketing partnerships for QRX003 in 60 countries that will help support its mission of ensuring that every patient, everywhere, can access Quoin's products, once approved.