Lead Product, QRX003, Being Tested in Two Active Registrational Clinical Studies for Netherton Syndrome Across the U.S., Europe, and the Middle East.
QRX003 Peeling Skin Syndrome Clinical Program Continues Following Positive Initial Data
Topical Rapamycin Development Programs Advancing Using Two Proprietary Delivery Technologies
ASHBURN, Va., July 29, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) (the "Company" or "Quoin"), a late clinical stage specialty pharmaceutical company focused on rare and orphan diseases, today provided an updated overview of its development product portfolio.
The company's lead product, QRX003 for Netherton Syndrome (NS), continues to advance in two pivotal registrational clinical studies. The studies are being conducted at clinical sites in the US, Europe and the Middle East. In each study QRX003 is applied twice-daily to greater than 80% of the subjects' complete body surface area (BSA) over a 12-week period. In the first study, QRX003 is being tested as monotherapy with no off-label systemic intervention. For subjects enrolled in the second study, QRX003 is dosed in conjunction with off-label systemic therapy. The clinical endpoints are identical for both studies and include an Investigator's Global Assessment (IGA), the Ichthyosis Area Severity Index (IASI), Pruritus (itch) as well as patient satisfaction scores (PASA). It is anticipated that each study will recruit between 12 to 16 subjects, with full recruitment targeted for early to mid Q1 2026.
QRX003 remains on track to potentially become the first approved treatment for NS and Quoin is targeting filing an NDA for regulatory approval in 2H 2026. Quoin plans to self-commercialize QRX003 in the US, Western Europe and Japan and has signed nine commercial partnerships covering 61 additional countries to support global access of the product once approved.
On May 14, 2025, Quoin announced positive initial data from its investigator led Peeling Skin Syndrome (PSS) clinical study which is being conducted in a single patient in New Zealand. The company reported positive data across key endpoints including a clinically meaningful two-grade improvement in the Investigator's Global assessment from 4 (severe) to 2 (mild), a substantial improvement in the Modified Ichthyosis Area Severity Index from 36 (scale 0-48) at baseline to 12 after 12 weeks of treatment with QRX003. In addition, in the validated Children's Dermatology Life Quality Index (CDLQI) endpoint, a substantial improvement from 19 (scale 0-30) at baseline to 11 was observed, Quoin intends to further expand this study and recruit an additional 4 to 6 subjects. There are currently no approved treatments or cures for PSS and the data released by Quoin represent the first known clinical findings for this disease.
Quoin's topical rapamycin program, which is being developed under a research agreement with The School of Pharmacy at University College Cork in Ireland, continues to progress. The program targets rare and orphan skin diseases including microcystic lymphatic malformations, venous malformations, and angiofibromas. Two proprietary delivery platforms are being evaluated including UCC's dissolvable microneedle technology and a Quoin in-licensed technology. Clinical testing of one or more selected formulations is anticipated to be initiated in the first half of 2026.
In light of the expected near-term completion of the QRX003 clinical program for NS, Quoin has discontinued the development of QRX007 for NS. QRX007 was being developed through Quoin's research agreement with The Queensland University of Technology (QUT) in Australia. Quoin's other research agreement with QUT for QRX008 remains in force. Finally, given the broad- based nature of its development portfolio, Quoin has decided to not advance the development of QRX004 as a potential treatment for Epidermolysis Bullosa (EB).
Dr. Michael Myers, Chief Executive Officer of Quoin commented, "We are very pleased to provide this very positive update on the status of our development product portfolio. This is a very exciting time for Quoin as we look to close out the QRX003 clinical program in Netherton Syndrome and release topline data from both studies early next year. We are actively transitioning Quoin into pre-commercialization mode in anticipation of the potential approval and launch of QRX003 in the next 18 to 24 months. We are also encouraged by the strong progress in our PSS and topical rapamycin programs which have helped inform our decision to focus our resources on these high potential opportunities and discontinue our second NS and EB programs. We look forward to providing additional updates on each of these products in due course."
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late 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, microcystic lymphatic malformations, venous malformations, angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
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, statements relating to continuing to advance QRX003 for NS in two pivotal registrational clinical studies, recruiting between 12 to 16 subjects for each study, targeting full recruitment for early to mid Q1 2026, QRX003 remaining on track to potentially become the first approved treatment for NS, Quoin targeting filing an NDA for regulatory approval in [2H 2026], plans to self-commercialize QRX003 in the US, Western Europe and Japan, supporting global access of the product once approved through nine commercial partnerships covering 61 additional countries, further expanding Quoin's PSS clinical study and recruiting an additional 4 to 6 subjects, advancing Quoin's topical rapamycin program, clinical testing of one or more selected formulations is anticipated in the first half of 2026, look to close the QRX003 clinical program in NS this year and release topline data from both studies in early next year, transitioning Quoin into pre-commercialization mode in anticipation of potential approval and launch in the next 18 to 24 months, providing additional updates on each of the products in due course 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, microcystic lymphatic malformations, venous malformations, angiofibromas 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 pursue its regulatory strategy; the Company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company's ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 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.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Dr. Michael Myers, Ph.D., CEO
[email protected]
Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341
