Quoin Pharmaceuticals Announces Recruitment of Three Additional Patients in Investigator Pediatric Netherton Syndrome Study and Provides Positive 9 month ‘Whole Body’ Data Update from Ongoing Study

Rhea-AI Summary

Quoin Pharmaceuticals (NASDAQ: QNRX) announced recruitment of three additional pediatric patients in an investigator‑led Netherton syndrome study and reported positive 9‑month whole‑body data from the first pediatric subject.

The subject's Investigator's Global Assessment (IGA) improved from 4 (severe) at baseline to 0 (clear) at 9 months, and pruritus fell from 5 to 0. The subject reports zero nightly sleep disturbance, no need for prior medications (antibiotics, antivirals, antihistamines, glucocorticoids), and no adverse events after 9 months of continuous daily QRX003 whole‑body dosing. Two new pediatric subjects are in Austria and one is in Ireland; all will receive twice‑daily whole‑body QRX003 with a 12‑week initial period followed by a long‑term extension.

Positive

• IGA 4→0 at 9 months (severe to clear)
• Pruritus 5→0 at 9 months
• No adverse events reported after 9 months of daily dosing
• Three additional pediatric recruits (2 Austria, 1 Ireland) enrolled

Negative

• None.

Insights

Clinical Development Expert

9‑month whole‑body data show full clinical response and no reported adverse events in one pediatric NS subject.

The data show a complete Investigator's Global Assessment improvement from 4 to 0 and pruritus falling from 5 to 0 after 9 months of daily QRX003, indicating resolution of visible disease and symptoms in this subject. The subject stopped prior supportive medications and reports zero nightly sleep disturbance, which are direct, patient‑level functional improvements.

Key dependencies and risks include limited sample size (single pediatric subject reported) and absence of reported safety events only up to 9 months; those facts constrain generalisability. Monitor enrollment progress of the three new pediatric subjects, their outcomes through the initial 12 weeks period and subsequent longer‑term extension for confirmation of durability and safety within the next several months.

Regulatory & Clinical Operations Expert

Investigator study reached enrolment target with three additional pediatric subjects; data augment early clinical evidence for QRX003.

The investigator‑led study now includes subjects in Austria and Ireland and plans twice‑daily whole‑body application for an initial 12 weeks followed by a long‑term extension until regulatory approval, which frames a clear operational pathway for gathering pivotal durability and safety data. The absence of adverse events through 9 months in the index subject strengthens an initial safety signal, but it remains early and limited to one reported pediatric case.

Immediate watch items are retention and adherence in the new pediatric enrollees, objective replication of the IGA and pruritus results, and timing of aggregate safety updates during the extension phase; these will determine regulatory relevance over the coming months.

• Recruitment of Three Additional Pediatric Patients in Austria and Ireland Achieves Investigator Study Target
• Current Pediatric Patient in Ongoing Study Has Completely Healed Skin After 9 months of ‘Whole Body’ Treatment
• Investigator’s Global Assessment (IGA) Materially Improved from Baseline 4 (Severe) to 0 (Clear)
• Pruritus (itch) Reduced from 5 at baseline to 0, reflecting a complete absence of pruritus
• High Durability of Treatment Effect of QRX003 with Continuous Daily Dosing
• Patient Continues Not to Require Previously Necessary Medications and is Experiencing Zero Nightly Sleep Disturbance
• No Adverse Events Reported After 9 Months of Continuous Dosing with QRX003
  
  

ASHBURN, Va., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces recruitment of three additional patients in its investigator led pediatric Netherton Syndrome (NS) study as well as highly positive 9 month clinical data from the first pediatric patient in the study.

After 9 months of continued whole body application of QRX003, the subject’s skin remains completely healed demonstrating the durability of ongoing daily treatment with the product. At baseline, prior to initiation of treatment with QRX003, the subject’s skin had an Investigator’s Global Assessment (IGA) of 4, on a scale of 0-4 where 4 is the most severe score possible. At 9 months, the IGA had materially improved to 0 and the subject’s skin is completely clear. In addition, the subject’s pruritus score (on a scale from 0-10, with 10 being the worst itch imaginable) changed from 5 at baseline to 0 at 9 months. The subject continues to experience zero nightly sleep disturbances without the need for any sedating medication, marking the first continuous period of uninterrupted sleep in their life. Furthermore, since being treated with QRX003, the subject has continued to have no requirement for previously necessary medications such as antibiotics, antivirals, antihistamines and glucocorticoids. No adverse events have been reported to date after 9 months of daily, whole-body treatment with QRX003.

In conjunction with the announcement of this highly positive data, Quoin is pleased to announce that it has recruited three additional pediatric subjects into this investigator led pediatric NS study. All three subjects will receive twice-daily whole-body application of QRX003, initially for a period of twelve weeks before continuing in a long-term extension protocol until regulatory approval has been obtained. Two of the subjects reside in Austria and the third lives in Ireland. Quoin believes data from these additional subjects will significantly add to the growing body of positive clinical data supporting QRX003 as a potential treatment for NS.

Quoin CEO Dr. Michael Myers, said, “We are pleased to announce these two significant milestone events for Quoin and our QRX003 NS program. First, the achievement of, and continued retention of, both fully healed skin and the complete elimination of pruritus in the first pediatric subject is a testament to the clinical benefit of QRX003 in NS. With no need for previously required medications, such as antibiotics, antivirals, antihistamines and glucocorticoids, and zero nightly sleep disturbance, treatment with QRX003 has truly been completely life transforming for this little girl. Second, we are excited to announce the recruitment of three additional NS subjects in Austria and Ireland. We believe that the clinical data from these subjects will continue to demonstrate positive clinical outcomes of QRX003 in NS without adverse events.”

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. For more information about Quoin’s current clinical trials please visit: https://www.nethertonsyndromeclinicaltrials.com/

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 several 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, 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: providing the additional subjects with twice-daily whole-body application of QRX003 for a period of twelve weeks before continuing in a long-term extension protocol until regulatory approval has been obtained; the data from the additional subjects significantly adding to the growing body of positive clinical data of QRX003 as a potential treatment for NS; the clinical data from the additional subjects demonstrating positive clinical outcomes of QRX003 in NS without adverse events ; 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, 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:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com

Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341

FAQ

What clinical improvement did QNRX report for the pediatric Netherton syndrome patient at 9 months?

The patient’s IGA improved from 4 to 0 and pruritus fell from 5 to 0 after 9 months of QRX003.

Did Quoin report any adverse events after 9 months of QRX003 treatment in the pediatric study?

No adverse events were reported after 9 months of continuous daily, whole‑body QRX003 dosing.

How many new pediatric patients were recruited for the QNRX investigator‑led Netherton study and where are they located?

Quoin recruited three additional pediatric subjects: two in Austria and one in Ireland.

What is the dosing plan for the new pediatric subjects in the QNRX Netherton study?

All three will receive twice‑daily whole‑body application of QRX003 for an initial 12 weeks then continue in a long‑term extension.

Has treatment with QRX003 changed the pediatric patient’s need for other medications?

Yes, the subject has not required prior medications such as antibiotics, antivirals, antihistamines, or glucocorticoids since starting QRX003.