Clinical Assessment Is Being Performed on a Pediatric Patient at Children’s Health Ireland in Dublin
First Evaluation of QRX003 in a Pediatric Patient
Second Clinical Site to Open in Spain with Potentially Three Additional Pediatric Netherton Patients
ASHBURN, Va., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a clinical-stage specialty pharmaceutical company focused on novel treatments for rare and orphan diseases, today announced that it has initiated the testing of the safety and efficacy of QRX003 in a young child with Netherton Syndrome (NS), a rare inherited genetic disease. There is currently no approved treatment for NS and no cure.
The clinical assessment is being led by Dr. Alan Irvine, a consultant dermatologist at Children’s Health Ireland and professor of dermatology at Trinity College Dublin. Dr. Irvine is president of the International Eczema Council and an elected member of the Royal Irish Academy. He has published over 250 peer-reviewed papers in high-impact journals, including many on epithelial genetics.
“We are pleased to announce this latest initiative for Quoin as we strive to generate the broadest and most diverse data set possible for QRX003 in Netherton Syndrome patients. Furthermore, we are delighted that Professor Irvine, one of the world’s leading researchers in this disease, has agreed to perform this assessment of QRX003. Currently, we are testing patients aged 14 years and up in our two ongoing clinical studies and we hope that data generated by Professor Irvine will facilitate lowering the eligibility age further. In addition, we look forward to broadening the scope of this clinical assessment to include three additional pediatric subjects in Spain,” said Dr. Michael Myers, Quoin CEO.
QRX003 is Quoin’s most advanced pipeline product and is currently being evaluated in two late-stage clinical trials as a potential treatment for NS under an open Investigational New Drug application with the U.S. Food and Drug Administration. Clinical data generated to date for QRX003 in NS patients has been promising with all evaluable subjects demonstrating improvement across a number of endpoints with no treatment-related adverse events recorded. In addition to the five open clinical sites in the United States, a sixth site is opening in Saudi Arabia. On October 22, Quoin also announced the planned opening of two additional clinical sites in the United Kingdom, each of which has a cohort of patients potentially eligible for recruitment.
About Netherton Syndrome Netherton Syndrome, a form of Ichthyosis, is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5) that leads to severe skin barrier defects and recurring infections, as well as a pronounced predisposition to allergies, asthma, and eczema. Patients often suffer from severe dehydration, chronic skin inflammation and stunted growth. Currently, there is no cure for Netherton Syndrome, nor are there any approved therapeutic treatments.
About QRX003 QRX003 is a topical lotion formulated with a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding, resulting in a highly porous and compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and the formation of a stronger and more effective skin barrier.
About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is an emerging 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, go to: www.quoinpharma.com.
Cautionary Note Regarding Forward Looking Statements The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, -a second clinical site to open in Spain with potentially three additional pediatric Netherton patients, the Company striving to generate the broadest and most diverse data set possible for QRX003 in Netherton Syndrome patients, the Company hoping that data generated by Professor Irvine will facilitate the Company lowering the eligibility age further, the Company opening a sixth site in Saudi Arabia, a planned opening of two additional clinical sites in the United Kingdom (each of which has a cohort of patients potentially eligible for recruitment), and Quoin’s products in development collectively having 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome, the clinical study may not be successful may not generate data which is sufficiently robust and comprehensive to support lowering the eligibility age further, the Company’s ability to open the planned sites as and when planned and and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
