Quoin Pharmaceuticals Announces FDA Clearance to Initiate Third Netherton Syndrome Clinical Study, A First of Its Kind
The rare and orphan disease focused clinical stage pharmaceutical company Quoin Pharmaceuticals (Nasdaq: QNRX) has announced FDA clearance to initiate a new QRX003 Netherton Syndrome (NS) clinical study. The “Whole Body” study will be conducted by Dr. Amy Paller at Northwestern University and is the and is the third Netherton Syndrome clinical study to be conducted under Quoin’s open Investigational New Drug application.
This groundbreaking announcement comes on the heels of the company’s recent release of positive interim clinical data from two of Quoin’s ongoing Netherton Syndrome clinical studies.
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 Netherton Syndrome. This new study is intended to generate data based on product use resembling potential real-world use therefore, it will be applied to over 80% of study participants’ body surface area. If approved, this would be 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.
Quoin CEO, Dr. Michael Myers, stated, “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.”
About Quoin Pharmaceuticals Ltd.
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.
