Quoin Pharmaceuticals announces positive interim clinical results for QRX003 in treating Netherton Syndrome with no safety concerns.
Quiver AI Summary
Quoin Pharmaceuticals Ltd. announced positive interim clinical data from an ongoing study of QRX003 for Netherton Syndrome, highlighting significant improvements in skin condition and patient satisfaction after 12 weeks of treatment. This follows positive findings from the first subject dosed in December 2024, demonstrating clear clinical benefits across all measured endpoints, including a reduction in skin severity and itchiness. No safety concerns were reported, and photographic evidence of the improvements is available on their website. Quoin's CEO expressed enthusiasm for these results, emphasizing the importance of these findings in supporting upcoming studies and a potential New Drug Application for QRX003 as a treatment for Netherton Syndrome.
Potential Positives
- Highly positive interim clinical data shows significant improvements across all measured endpoints in the first subject dosed with QRX003 after 12 weeks.
- No safety concerns have been reported in the ongoing clinical study of QRX003 for Netherton Syndrome.
- The impending initiation of a 'whole body' clinical study under an FDA-cleared open IND application indicates a progression towards a potential New Drug Application filing for QRX003.
- Patient satisfaction scores have shown continued improvement, reinforcing the efficacy and potential of QRX003 as a treatment option.
Potential Negatives
- Potential over-reliance on positive interim results from a single subject could mislead stakeholders about the overall efficacy of QRX003, as the data may not be representative of broader study outcomes.
- The press release emphasizes positive results while downplaying the inherent risks associated with ongoing clinical trials, which could lead to unrealistic expectations among investors and patients.
- Quoin Pharmaceuticals faces significant challenges in successfully obtaining FDA approval for QRX003, as indicated by the cautionary note regarding forward-looking statements that highlights the uncertainties surrounding their clinical studies and potential treatment efficacy.
FAQ
What clinical data has been released for QRX003?
Quoin Pharmaceuticals announced positive interim clinical data showing improvements in all measured endpoints for the first subject dosed with QRX003.
What is the significance of the study results for QRX003?
The study results indicate marked improvement in skin condition and patient satisfaction, suggesting the potential efficacy of QRX003 for Netherton Syndrome.
What are the next steps for Quoin Pharmaceuticals regarding QRX003?
Quoin anticipates the initiation of a 'whole body' clinical study and aims to file a New Drug Application for QRX003.
What is Netherton Syndrome?
Netherton Syndrome is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene, leading to severe skin issues and complications.
Is QRX003 safe for patients?
No safety concerns have been reported in any of the Quoin Netherton studies conducted to date, indicating a favorable safety profile for QRX003.
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
Highly Positive Clinical Data on Completion of Testing for First Subject Dosed Twice Daily with QRX003 in Open-Label Study
Demonstrated Clinical Benefits from QRX003 Observed Across All Measured Endpoints
Before and After Dosing with QRX003 Photographs Available for Review On Website
No Product Safety Concerns Identified in Any Quoin Netherton Study to Date
ASHBURN, Va., Jan. 06, 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 additional positive interim clinical data from one of its ongoing Netherton Syndrome clinical studies.
In December 2024, Quoin announced positive data from the first subject dosed twice-daily in Quoin’s ongoing open-label study after 6-weeks of dosing with QRX003, marking the midpoint of testing. The Company is now pleased to share clinical data for that subject upon completion of testing. The following table illustrates the clear improvements observed for this subject from baseline through 12 weeks of twice-daily dosing with QRX003 across all measured clinical endpoints.
Table 1: First Patient Data from Open Label Study Part B- Dosed Twice Daily with QRX003
End Point | Baseline | 6 weeks | 12 weeks |
M-IASI* | 18 | 4 | 3 |
WINRS** | 7 | 4 | 2 |
IGA*** | Moderate | Mild | Almost Clear |
*
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.
**
WINRS
: Worst Itch Numeric Rating Scale, which measures the severity of itch on an 11-point scale (0 = no itch, 10 = worst imaginable itch).
***
IGA
: Investigator’s Global Assessment, which uses descriptive categories (e.g., clear, mild, moderate, severe) to evaluate the overall severity of Netherton Syndrome symptoms.
Photographs illustrating the improvements in the subject’s skin appearance can be accessed via the link below and are available on Quoin’s website.
https://quoinpharma.com/pipeline/#trials
In addition, the patient satisfaction scores across multiple assessed metrics which were highly positive after 6 weeks of testing demonstrated even further improvement after 12 weeks. No safety concerns were reported for the subject throughout the study.
Quoin CEO, Dr. Michael Myers, said, “We are very excited to announce continued positive results from our ongoing Netherton Syndrome clinical studies. With the availability of photographic evidence that clearly demonstrates the profound change in skin appearance for this subject in our open-label study, we believe we are continuing to develop a growing body of evidence of the potential efficacy of QRX003 in Netherton Syndrome. The marked improvement demonstrated across all measured endpoints is highly encouraging. Furthermore, and importantly, the patient satisfaction scores with QRX003 continue to be very positive, with no safety concerns observed.
We are eagerly awaiting the initiation of our ‘whole body’ clinical study, which will be conducted by Dr. Amy Paller at Northwestern University. We previously announced FDA clearance to proceed with this study under an open Investigational New Drug (IND) application in December and anticipate that clinical data from this study will become a key component of the data package we are assembling to support a New Drug Application (NDA) filing for QRX003 as potentially the first approved treatment for Netherton Syndrome. 2025 is already off to an exciting start for Quoin and we look forward to providing additional updates throughout the year.”
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 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, - potential efficacy of QRX003 as a treatment for Netherton Syndrome, await the initiation of our ‘whole body’ clinical study, which will be conducted by Dr. Amy Paller at Northwestern University, anticipate that clinical data from the whole body study will become a key component of the data package the Company is assembling to support a New Drug Application (NDA) filing for QRX003 as potentially the first approved treatment for Netherton Syndrome,), 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, its studies may not be successful or may not generate data which is sufficiently robust and comprehensive to 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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