Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003. QRX003 is a topical lotion that contains a broad-spectrum serine protease inhibitor designed to target the kallikreins in the skin responsible for the excessive skin shedding associated with this disease.
The study will be conducted by Dr. Amy Paller, of Northwestern University. It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period. By comparison, in Quoin’s ongoing open-label and double-blinded clinical studies, QRX003 is applied to approximately 20% of the subject’s BSA, typically the arms and lower leg. This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date. It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS.
Dr. Amy Paller said, “The best kind of treatment, short of curative gene therapy, focuses on reversing the mechanism by which skin disease occurs. Targeting kallikreins, which are thought to lead to the clinical manifestations of Netherton Syndrome, could be an ideal approach.”
Quoin CEO, Dr. Michael Myers, added, “Following our recent announcement of positive interim clinical data from two of our ongoing Netherton Syndrome clinical studies, we are very excited to announce FDA clearance to initiate this groundbreaking additional study for QRX003, where the product will be applied to greater than 80% of each subject’s body surface area. We are extremely pleased to be working with Dr. Paller on this new study and look forward to generating data in a real-world setting, which will be a key component of our future filing. This will be Quoin’s third clinical study in NS subjects to be conducted under our open Investigational New Drug application and reflects our absolute commitment to generating the most robust and diverse data set possible to support our mission of delivering the first-ever approved treatment for this horrendous disease.”
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