By M. Marin
NASDAQ:QNRX
READ THE FULL QNRX RESEARCH REPORT
FDA clears initiation of 2nd NS pivotal whole body clinical study for QRX003, CL-QRX003-002
Quoin Pharmaceuticals (NASDAQ:QNRX) reported 2Q25 results today and provided a business update. The company is a clinical stage, specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with an initial focus on dermatological conditions. The company’s lead asset is QRX003, which is being evaluated for the treatment of Netherton Syndrome (NS), pediatric NS and Peeling Skin Syndrome (PSS).
QNRX has active Netherton Syndrome (NS) studies that are being conducted concurrently under an FDA open Investigational New Drug (IND) application to assess QRX003 for treatment of NS. QNRX continues to generate positive interim results from these and other studies it is conducting. QRX003 is a topical lotion with a broad-spectrum serine protease inhibitor that has demonstrated the ability to significantly downregulate the hyperactivity of the kallikreins in the skin that are responsible for the excessive skin shedding that is associated with NS and other dermatological diseases. Clinical data from Quoin’s ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances.
Quoin believes it could potentially file an NDA for regulatory approval in 2026
Moreover, the FDA recently granted QRX003 Rare Pediatric Disease (RPD) Designation for the treatment of NS. The European Medicines Agency (EMA) earlier had granted Orphan Drug Designation to QRX003. The company believes these designations reinforce the potential of QRX003 as a therapeutic candidate as it advances clinical studies towards a potential New Drug Application (NDA) for QRX003 as the first approved treatment for NS. If an NDA for QRX003 is approved, Quoin may be eligible for a Priority Review Voucher (PRV). The voucher can be used to obtain faster priority review or it can be monetized through selling it to another company.
There are no approved NS treatments currently and Quoin is optimistic about QRX003’s prospects to be the first approved treatment for NS. The overall patient population is fairly sizable. Quoin estimates that there are about 6,000-7,000 patients in the U.S. and EU suffering with Netherton syndrome. Data is not readily available and these estimates are within the range of other published estimates. The National Organization for Rare Disorders (NORD) indicates that the actual number of people suffering from Netherton syndrome might exceed the number of reported cases because it is often undiagnosed.
Second NS pivotal whole body clinical study for QRX003, CL-QRX003-002
The company is also expanding its clinical activities around QRX003 for the treatment of NS and other rare dermatological conditions, with several recent FDA approvals to initiate new studies. QNRX received FDA clearance to initiate a second NS pivotal whole body QRX003 clinical study for NS, CL-QRX003-002, which is designed to build upon positive clinical data from an earlier trial in which QRX003 was applied to the arms and lower legs, representing about 20% of the subject’s body surface area (BSA).
In QRX003-002, QRX003 will be applied twice daily to at least 80% of the BSA in about 12 to 15 participants. Study QRX003-002 will therefore generate more extensive safety and efficacy data and also match real-world usage if QRX003 obtains regulatory approval. QRX003 will be studied as an adjuvant treatment for NS in participants who are currently receiving and will continue to receive off-label systemic therapy during for study. Conversely, study CL-QRX003-003 is designed to assess QRX003 as a monotherapy.
With Studies CL-QRX003-002 and CL-QRX003-003 and other activities, Quoin is studying QRX003 as a monotherapy and as an adjuvant therapy for treatment of NS. The company is building a robust database and, depending on the data from the studies, potentially increasing pathways to regulatory approval, in our view. Quoin expects its clinical activities will produce a solid database that will be key to its regulatory approval submission supporting the safety and efficacy of QRX003.
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