Quoin Pharmaceuticals Initiates Clinical Testing of QRX003 in Pediatric Netherton Syndrome Patient

• Quoin Pharmaceuticals has begun clinical testing of QRX003 in a young child with Netherton Syndrome at Children’s Health Ireland, marking the first evaluation of the drug in a pediatric patient.
• The clinical assessment is led by Dr. Alan Irvine, a leading researcher in Netherton Syndrome, aiming to broaden the data set for QRX003 and potentially lower the eligibility age for treatment.
• In addition to five open clinical sites in the United States, Quoin plans to open a sixth site in Saudi Arabia and two more in the United Kingdom to expand patient recruitment.
• QRX003, a topical lotion, is being evaluated in late-stage clinical trials as a potential treatment for Netherton Syndrome, with promising early data showing improvement across multiple endpoints.

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) has commenced clinical testing of QRX003, a topical lotion, in a young child diagnosed with Netherton Syndrome (NS). This assessment, a first for a pediatric patient, is underway at Children’s Health Ireland in Dublin, under the guidance of Dr. Alan Irvine, a consultant dermatologist and professor at Trinity College Dublin.

Clinical Assessment Details

The clinical assessment led by Dr. Irvine, aims to evaluate the safety and efficacy of QRX003 in this rare genetic condition. Netherton Syndrome, characterized by severe skin barrier defects and recurring infections, currently lacks an approved treatment or cure. Dr. Michael Myers, CEO of Quoin, expressed enthusiasm for the initiative, highlighting the importance of generating a broad data set for QRX003. The company hopes the data will support lowering the eligibility age for treatment with QRX003.

QRX003: Mechanism of Action

QRX003 is formulated with a proprietary delivery technology containing a broad-spectrum serine protease inhibitor. It is designed to mimic the function of LEKTI, a protein deficient in Netherton Syndrome patients, which leads to excessive skin shedding and a compromised skin barrier. The lotion aims to normalize skin shedding and strengthen the skin barrier.

Ongoing Clinical Trials and Expansion

QRX003 is currently in late-stage clinical trials under an open Investigational New Drug application with the U.S. Food and Drug Administration. Prior clinical data has shown promising results, with improvements observed across multiple endpoints and no treatment-related adverse events reported. In addition to the existing clinical sites in the United States, Quoin plans to open additional sites in Saudi Arabia and the United Kingdom, expanding the reach of the trials and the potential patient pool.

About Netherton Syndrome

Netherton Syndrome is a rare hereditary skin disorder resulting from a mutation in the SPINK5 gene. This mutation leads to severe skin barrier defects, recurring infections, and a predisposition to allergies, asthma, and eczema. Patients often experience severe dehydration, chronic skin inflammation, and stunted growth. The absence of approved treatments underscores the unmet medical need for effective therapies.