Quoin Pharmaceuticals reports significant skin improvement in pediatric Netherton Syndrome patients after six weeks of QRX003 treatment.
Quiver AI Summary
Quoin Pharmaceuticals Ltd. announced positive interim results from its clinical study of QRX003 for treating Pediatric Netherton Syndrome, showing significant improvements in skin appearance. After six weeks of twice-daily dosing, the subject's condition improved from "Severe" to "Mild," leading to an expansion of the treatment area from 20% to the whole body. No adverse events have been reported, and the results support the decision to transition to whole-body treatment for further evaluation. Quoin plans to expand the study to include more pediatric subjects, believing that these developments may establish QRX003 as a safe and effective treatment for this rare skin disorder, which currently has no approved therapies.
Potential Positives
- Significant improvement in skin condition for study subject, with disease classification improving from "Severe" to "Mild" after six weeks of treatment with QRX003.
- Expansion of treatment area from 20% to "Whole Body" indicates growing confidence in the product's efficacy.
- No adverse events or safety concerns reported in the ongoing study, suggesting a favorable safety profile for QRX003.
- Plans to expand the study to include additional pediatric subjects in other countries, potentially increasing the scope and impact of the research on Netherton Syndrome treatments.
Potential Negatives
- Despite the reported positive interim clinical data, the press release heavily relies on forward-looking statements, which carry risks and uncertainties that could affect actual outcomes.
- The fact that there is currently no approved therapeutic treatment for Netherton Syndrome raises concerns about the commercial viability of QRX003, as well as the company's ability to meet regulatory requirements.
- The transition of the pediatric subject to “whole body” treatment may imply that initial localized treatment was not fully effective, potentially indicating limitations in the product's efficacy.
FAQ
What is the key finding from the recent Quoin Pharmaceuticals study?
The study showed significant skin improvement in Netherton Syndrome patients, with conditions improving from “Severe” to “Mild” after six weeks.
What is QRX003 and how does it work?
QRX003 is a topical lotion designed to promote skin barrier function by acting as a serine protease inhibitor, mimicking a missing protein called LEKTI.
How is the ongoing pediatric study progressing?
The pediatric study is expanding to whole body treatments after positive interim results, indicating promising safety and efficacy of QRX003.
What condition does QRX003 aim to treat?
QRX003 targets Netherton Syndrome, a rare hereditary skin disorder characterized by severe skin barrier defects and related health issues.
Are there any safety concerns reported during the clinical trials?
There have been no adverse events or safety concerns reported so far in this and other Quoin clinical studies involving Netherton Syndrome subjects.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Continued Significant Improvement in Skin Appearance Observed in Study
Subject’s Disease Classification Improved from “Severe” to “Mild” after 6 Weeks Dosing
Treatment area expanded from 20% Body Surface Area to “Whole Body”
ASHBURN, Va., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces positive interim clinical data from its ongoing Investigator Pediatric Netherton Syndrome clinical study.
The Investigator Pediatric Study continues to demonstrate significant improvement in the skin area treated with QRX003 versus the non-treated area. At the mid-point of the testing period the Investigator’s Global Assessment (IGA) of the skin condition improved from “Severe” at baseline to “Mild” after six weeks of dosing twice a day with QRX003, indicating a very substantial improvement in a short period of testing. As a result of these positive results, the subject is being transitioned to having QRX003 applied to their whole body surface area (BSA) as opposed to the approximately 20% of their BSA that was being tested for the initial 6 weeks.
In addition, there have been no adverse events or safety concerns reported to date for this subject, which is consistent with observations from each of Quoin’s ongoing clinical studies in Netherton Syndrome subjects.
Quoin CEO, Dr. Michael Myers, said, “Earlier this week we shared positive data from our ongoing open label clinical study in subjects aged 14 years and older and provided photographic evidence of the improvement in that subject’s skin, which is accessible via this
link
. Today, we are very pleased to announce another positive update from our pediatric study across a number of clinical endpoints for the subject in this study. The significant improvement in the Investigator’s Global Assessment (IGA) from Severe at Baseline to Mild-Moderate after 12 days of dosing, and now to Mild after 6 weeks of dosing is truly remarkable, and we believe that the investigator’s decision to transition the subject to “whole body” treatment is an exciting step forward that will provide even more representative data on the potential safety and efficacy of QRX003 in Netherton Syndrome patients. We look forward to expanding this study to include additional pediatric subjects in other countries, and we believe each of these subjects may have an opportunity to move directly to whole body testing based on the positive nature of the results generated to date. With this study well underway and the adult “whole body” study cleared to proceed by the FDA, we are beginning to assemble what we hope will be very compelling clinical evidence that supports the potential of QRX003 as a safe and effective treatment for Netherton Syndrome patients.”
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 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, Epidermolysis Bullosa 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,” “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 belief that the decision to transition the pediatric subject to “whole body” treatment will provide even more representative data on the safety and efficacy of QRX003 as a treatment for Netherton Syndrome; expanding the study to include other pediatric subjects in other countries, the belief that such subjects may may have an opportunity to move directly to whole body testing based on the results generated to date, beginning to assemble what we hope will be very compelling clinical evidence that supports the potential of QRX003 as a safe and effective treatment for Netherton Syndrome patients 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; whether its studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRXOO3 as an approved treatment for Netherton Syndrome; 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.
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
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