Three Arm, Randomized, Double-Blind, Vehicle Controlled Study Will Test Two Doses of QRX003 Versus Vehicle
ASHBURN, Va. -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a specialty pharmaceutical company focused on rare and orphan diseases, announces that the first clinical site has now been fully opened for its clinical study to evaluate QRX003 for the treatment of the rare genetic disease, Netherton Syndrome. The opening of additional sites is in process and patient recruitment is expected to begin shortly.
This randomized, double blinded, vehicle-controlled study is being conducted under a U.S. Investigational New Drug (IND) Application and 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.
Quoin CEO, Dr. Michael Myers, said, “We are very pleased to announce another significant milestone in the development of QRX003 for this very underserved patient population. The opening of this first clinical site, with full Institutional Review Board approval, is testimony to the great work of our CRO, Therapeutics Inc. With the opening of additional sites well underway, we are poised to initiate patient recruitment shortly.
“This is also an important step forward for our partners with whom we have established supply and distribution agreements for QRX003 in 60 countries, as it potentially advances the path to approval in their territories. Furthermore, many of these regions have early-access programs that the data from this study could potentially enable QRX003 to participate in, and be made available on a named patient basis prior to formal regulatory approval.”
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 that will help support its mission of ensuring that every patient, everywhere, can access Quoin’s products, once approved.
Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
