Quoin Pharmaceuticals Announces Acceptance of QRX003 Paper in Dermatology and Therapy

Four of six pediatric patients in the Compassionate Use Program were classified as improved from baseline in June.

Rhea-AI Summary

Quoin Pharmaceuticals (NASDAQ: QNRX) announced acceptance of a peer-reviewed paper on investigational QRX003 for publication in Dermatology and Therapy.

The paper introduces the topical lotion’s mechanism in Netherton Syndrome and describes Professor Alan Irvine’s treatment of one pediatric patient under Quoin’s Compassionate Use Program. The case report describes fully healed skin, elimination of itching and resulting nightly sleep disturbances, and reduced need for previously required medications.

Separately, an August interim analysis of the ongoing Phase 2/3 study evaluated the first six participants completing 12 weeks of QRX003 4% lotion. Four of six (66.7%) achieved the primary endpoint: at least a 1-grade improvement on the Investigator Global Assessment, a clinician-rated assessment (p=0.0087 versus a pre-specified alpha of 0.0215).

5 points · 1 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 1 point

How the balance works

Positive

• Major pointPhase 2/3 primary endpoint achieved by four of six (66.7%) after 12 weeks; p=0.0087 versus alpha 0.0215.
• Minor pointPediatric case report describes fully healed skin, eliminated itching-related nightly sleep disturbances and reduced medication needs.
• Minor pointCompassionate Use Program: four of six pediatric patients classified as ‘Improved’ or ‘Significantly Improved’ from baseline in June.
• Minor pointCompassionate Use Program had no treatment-related adverse events reported in the June update.
• Minor pointQRX003 manuscript accepted for publication in the peer-reviewed journal Dermatology and Therapy.

Negative

• Minor pointPhase 2/3 findings remain interim, covering only the first six participants completing 12 weeks of treatment.

News Explained

Quoin also reports that in June, four of the six pediatric patients then enrolled in its Compassionate Use Program were classified as “Improved” or “Significantly Improved” from baseline across key clinical endpoints, and no treatment-related adverse events were reported.

Key Figures

Pediatric compassionate-use patients improved: 4 of 6 patients Primary endpoint responders: 4 of 6 (66.7%) Primary endpoint p-value: p=0.0087

Pediatric compassionate-use patients improved

4 of 6 patients

Classified as 'Improved' or 'Significantly Improved' across key clinical endpoints

Primary endpoint responders

4 of 6 (66.7%)

Phase 2/3 interim analysis; at least a 1-grade Investigator Global Assessment improvement after 12 weeks

Primary endpoint p-value

p=0.0087

Compared with a pre-specified alpha of 0.0215

Historical Context

1 past event · Latest: Aug 28

1 event

1. Aug 28

   Phase 2/3 data

   24h Move

   +18.7%

   Four of six participants met the primary endpoint, with a statistically significant improvement at Week 12.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

serine protease inhibitor, investigator global assessment, pre-specified alpha, compassionate use

4 terms

serine protease inhibitor medical

"investigational topical serine protease inhibitor lotion"

A serine protease inhibitor is a drug or molecule that blocks a type of enzyme—called a serine protease—that cuts other proteins as part of normal body processes like blood clotting, digestion, immune response or viral replication. Investors care because these inhibitors can be developed into medicines that alter disease pathways; their success affects a company’s clinical progress, regulatory risk and potential market value much like a key that can lock an important biological ‘scissor’ from doing damage or causing disease.

investigator global assessment medical

"improvement in Investigator Global Assessment"

A clinician’s overall rating of a patient’s disease severity or improvement in a medical study, recorded on a standard numerical or descriptive scale. It serves as a key measure of whether a treatment appears to work; for investors, strong or weak results on this score can sway trial outcomes, regulatory approval chances and a drug’s commercial prospects, like a referee’s score influencing the final result of a contest.

pre-specified alpha technical

"vs. a pre-specified alpha of 0.0215"

The significance level (type I error rate) that researchers agree on and record before examining trial or study results; it sets the p-value threshold used to decide whether an observed effect is statistically significant. Pre-specifying alpha prevents data-dependent changes to the threshold after seeing outcomes, and in studies with multiple endpoints or interim analyses it is often partitioned or adjusted (for example by multiplicity corrections or alpha spending rules) so the overall chance of a false positive is controlled.

compassionate use regulatory

"under Quoin’s Pediatric Compassionate Use Program"

Compassionate use is a regulated program that lets patients access an experimental drug or medical device outside a formal clinical trial when no approved treatment is available. For investors, it matters because such access can provide early real-world safety and demand signals, affect regulatory relationships and public perception, and slightly alter near-term revenue prospects or liability exposure — similar to a company offering a prototype to select customers before full approval.

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• Peer-Reviewed Paper Introduces QRX003 and Its Mechanism of Action in Netherton Syndrome
• Case Report Details Professor Alan Irvine’s Clinical Experience Treating a Pediatric Patient Under Quoin’s Compassionate Use Program

ASHBURN, Va., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that a manuscript titled “An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report” has been accepted for publication in a forthcoming issue of Dermatology and Therapy.

The peer-reviewed paper introduces QRX003, the Company’s investigational topical serine protease inhibitor lotion, and describes its mechanism of action in Netherton Syndrome. It also presents a case report from Professor Alan Irvine, consultant dermatologist at Children’s Health Ireland and professor of dermatology at Trinity College Dublin, describing his positive clinical experience treating a pediatric patient with QRX003 under Quoin’s Pediatric Compassionate Use Program. The paper describes the impact that QRX003 has had on the patient leading to fully healed skin, complete elimination of pruritus (itch) which has led to zero nightly sleep disturbances as a result and significant reduction in need for all previously required medications.

In June, Quoin reported that four of the six pediatric patients then enrolled in the Compassionate Use Program were classified as ‘Improved’ or ‘Significantly Improved’ from baseline across key clinical endpoints, with no treatment-related adverse events reported.

Separately, in August Quoin reported positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in Netherton Syndrome. In the interim analysis of the first six participants to complete 12 weeks of treatment, four of six (66.7%) achieved the primary endpoint of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087 vs. a pre-specified alpha of 0.0215).

“Acceptance of this paper by a peer-reviewed dermatology journal is important recognition of the scientific rationale behind QRX003 and its potential in Netherton Syndrome. We are grateful to Professor Irvine for documenting his clinical experience treating a pediatric patient with QRX003,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “Because Netherton Syndrome is a genetic disease, the experience of pediatric patients is especially important as we advance QRX003. This case report adds to the growing body of clinical evidence supporting the program, including the positive interim results from our ongoing Phase 2/3 study.”

About Netherton Syndrome

Netherton Syndrome is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the United States indicated specifically for Netherton Syndrome.

About QRX003

QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan. QRX003 lotion (4%) is currently being evaluated in whole-body clinical trials in patients with Netherton Syndrome, including the Phase 2/3 study CL-QRX003-004.

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 is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, 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 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. This press release contains forward-looking statements. 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: QRX003 potentially becoming the first approved treatment for Netherton Syndrome; QRX003 having the potential to change the course of Netherton Syndrome in patients treated with this product; and Quoin’s belief that its products in development collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, 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, 2025 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
mmyers@quoinpharma.com

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Quoin’s QRX003 pediatric case report show?

The case report describes fully healed skin, complete elimination of itching and resulting nightly sleep disturbances, and reduced need for previously required medications. It concerns one pediatric patient treated by Professor Alan Irvine under Quoin’s Pediatric Compassionate Use Program.

What did Quoin report about QRX003’s pediatric Compassionate Use Program in June?

Four of the six pediatric patients then enrolled were classified as ‘Improved’ or ‘Significantly Improved’ from baseline across key clinical endpoints. No treatment-related adverse events were reported.