Quoin Pharmaceuticals Announces Initial Positive Clinical Data for QRX003 from Pediatric Peeling Skin Syndrome Study

• Clear Improvement in Patient's Skin Appearance Observed in Study after 12 weeks Compared to Baseline
• Key endpoints including Investigator's Global Assessment (IGA), Modified Ichthyosis Area Severity (M-IASI) and Children's Dermatology Life Quality Index (CDLQI) all demonstrated improvement from baseline
• QRX003 is being well tolerated and no adverse events have been reported
• Patient is expected to continue to be treated with QRX003 to assess progress
• Company continues to advance QRX003 in its late-stage Netherton Syndrome clinical studies
  
  

ASHBURN, Va., May 14, 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 announces positive initial clinical data from its ongoing Investigator Pediatric Peeling Skin Syndrome clinical study.

As the table below illustrates, after 12 weeks of treatment, clear evidence of skin healing in the area treated with QRX003 compared to baseline was observed.

*M-IASI: Modified Ichthyosis Area of Severity Index, a score used to assess the severity and extent of skin symptoms associated with ichthyosis. Lower scores indicate improvement.

**IGA: Investigator's Global Assessment, which uses descriptive categories (e.g., clear, mild, moderate, severe) to evaluate the overall severity of disease symptoms.

*** CDQLI: The Children's Dermatology Life Quality Index is a validated clinical tool designed for children aged 4-15 that is used to measure the impact of their skin disease on a child's quality of life in terms of symptoms, leisure activities, sleep, school, personal relationship and treatment. The scale for the CDQLI is 0-30.

QRX003 is being well tolerated by the patient and no adverse events have been reported. As a result of these positive initial results, the patient is expected to continue to be treated with QRX003 with a further clinical assessment by the investigator scheduled after 24 weeks of treatment.

Quoin CEO, Dr. Michael Myers, said, "We are very pleased to announce such positive initial data across a number of clinical endpoints for the pediatric subject in this study, which we believe may be the first formal clinical study for this disease. The two grade improvement, which is accepted as being clinically meaningful in both the Investigator's Global Assessment (IGA) (severe to mild) and the M-IASI (moderate to clear) after 12 weeks of QRX003 application is very encouraging. We fully support the investigator's decision to continue treatment. In addition, the validated CDQLI questionnaire results to date indicate that the pediatric subject in the study is experiencing a distinct positive improvement in their quality of life as a result of ongoing treatment with QRX003. Consistent with what we are observing in our Netherton Syndrome studies, QRX003 is well tolerated with no adverse events reported. We look forward to expanding this study to include additional pediatric subjects in other countries and to advancing the clinical development of the product for this disease. There is currently no approved treatment or cure for peeling skin syndrome and there are no clinical studies listed on clinicaltrials.gov as actively recruiting and dosing subjects, thus presenting a further opportunity for Quoin to potentially achieve the first regulatory approval for another rare genetic disease. We are also continuing to advance QRX003 in our late-stage Netherton Syndrome clinical studies."

About Peeling Skin Syndrome (PSS)

Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS, and patients try to manage symptoms using over-the-counter emollients.

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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 descriptions 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," "hope," "plan," "potential," "anticipate," "look forward," "believe," "may," 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: the patient continuing to be treated with QRX003 to assess progress; Quoin's Pediatric Peeling Skin Syndrome clinical study being the first formal clinical study for this disease, expanding the study to include additional pediatric subjects in other countries, advancing the clinical development of a product for Peeling Skin Syndrome, achieving the first regulatory approval for another rare genetic disease, advancing QRX003 in Quoin's late-stage Netherton Syndrome clinical studies 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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:

Investor Relations

PCG Advisory

Jeff Ramson

[email protected]

(646) 863-6341