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2 weeks ago
Quoin Pharmaceuticals Announces Highly Positive βWhole Bodyβ Clinical Data from Ongoing Pediatric Netherton Syndrome Study
Groundbreaking data from first whole body application of QRX003 underscores potential efficacy
Transformational improvement in disease state after just 2 weeks of treatment
Clear visual evidence of skin healing observed
Improvement has eliminated need for previously required medications
Patient is now experiencing zero nightly sleep disturbance for the first time
No adverse events reported from whole body treatment
ASHBURN, Va., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the βCompanyβ or βQuoinβ), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study. Dramatic improvement was observed in the patientβs disease state with clear visual evidence of skin healing observed after just two weeks of whole-body application of QRX003. No adverse events have been reported to date.
Both key clinical endpoints, Investigatorβs Global Assessment (IGA) and Pruritus or itch, demonstrated highly significant clinical improvements from baseline after two weeks of treatment with QRX003 on patientβs whole body.
Table 1: Results for First Pediatric Patient Receiving QRX003 βWhole-Bodyβ Application
Endpoint* Baseline Two Week
Investigator Global Assessment 7 1-2
Pruritus 5 1
*Both IGA and Pruritus scores based on a 0-10 scale.
Furthermore, following treatment with QRX003, the patient has now discontinued previously required medications including all antihistamines, glucocorticoids and antivirals. Importantly, the patient has not needed treatment with any antibiotics since the whole-body application of QRX003 was initiated. In addition, the patient is now experiencing zero nightly sleep disturbances for the first time in her life. No adverse events have been reported to date.
Quoin CEO Dr. Michael Myers, said, βWhile cautioning upfront that this data is from just a single patient over a short period of time, these truly exciting and groundbreaking results provide a snapshot of the potential efficacy of QRX003 as a chronic whole-body treatment of Netherton Syndrome. After just two weeks of treatment, a transformational life change has occurred for this first patient to receive whole-body application of QRX003. At baseline, the Investigators Global Assessment, or IGA, for the patientβs skin was at 5 on a scale of 0-10. After two weeks of treatment with QRX003, the IGA was at 1, representing an almost complete elimination of the visual effects of the disease on the patientβs skin. In addition, her pruritus, which at baseline was described as βchronically debilitating itchβ and a 7 on of a scale of 0-10, had significantly dropped to a βhighly tolerable and non-intrusiveβ score of between 1 and 2 after only two weeks of treatment with QRX003. Even more encouraging is the fact that the patient has been able to discontinue ongoing treatment with a variety of previously required medications including antihistamines, antivirals, glucocorticoids and she has not needed any antibiotics since the initiation of dosing with QRX003. We believe that these results indicate that QRX003 is directly targeting the root cause of the disease and has the potential to provide NS patients with the opportunity to have lives essentially free from the ravages of this terrible disease. In addition, the patient is now, for the first time, experiencing zero nightly sleep disturbances, again providing additional evidence of the potential efficacy of QRX003. Finally, we are very pleased to report that no adverse events have been recorded after two weeks of twice-daily, whole-body application of QRX003. As we continue with our plans to expand this study to include additional pediatric subjects in other countries who would also receive whole body application of QRX003, we believe that the highly encouraging nature of the results generated to date for this patient could potentially bring hope and comfort to children and families whose lives are being so dramatically impacted by the consequences of this cruel disease.β
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.
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2 months ago
Skinvisible Reports Licensee Success in Netherton Syndrome Clinical Studies
LAS VEGAS, NV / ACCESS Newswire / January 23, 2025 / Skinvisible Pharmaceuticals, Inc. ("Skinvisible" or "the Company"), (OTCQB:SKVI), an innovative topical and transdermal pharmaceutical research and development company, with proprietary Invisicare® drug delivery technology, today announces significant achievements in 2024 and 2025, through its licensee Quoin Pharmaceuticals' progress in Netherton Syndrome treatment.
Skinvisible granted Quoin an exclusive, royalty-bearing license to its technology for use in select rare skin diseases and for the right to use its proprietary formula for Netherton Syndrome. Netherton Syndrome is a hereditary disorder affecting the skin, hair, and immune system, currently lacking an approved treatment or cure. Quoin is responsible for obtaining all FDA and other regulatory body approvals necessary to market the products in the US and other countries. Upon the successful completion of FDA or EU approval, Skinvisible is entitled to receive a milestone payment of $5 million and ongoing royalties from sales.
LICENSEE CLINICAL AND REGULATORY SUCCESS:
Skinvisible's licensee, Quoin Pharmaceuticals, Inc. (NASDAQ:QNRX) reported multiple positive developments for QRX003, which utilizes Skinvisible's Invisicare technology and its formulation for the rare skin disease: Netherton Syndrome:
Key Recent Developments:
FDA clearance for Netherton Syndrome "whole body" study at Northwestern University
Significant clinical improvements in both open label and pediatric studies including subject's disease classification improved from "severe" to "mild" after 6 weeks dosing
No adverse events or safety concerns reported to date from each of Quoin's ongoing clinical studies in Netherton Syndrome subjects
International expansion of studies to UK, Ireland, and Saudi Arabia
Netherton Syndrome product QRX003 with Invisicare delivery technology licensed in 60 countries
"We anticipate a significant milestone with our licensee potentially receiving the first FDA approval for a formulation using our Invisicare delivery technology," said Terry Howlett, President and CEO of Skinvisible. "This validates our strategy of developing innovative topical and transdermal therapeutics for other indications. As our licensee advances their clinical trials, we remain committed to supporting their efforts to bring this groundbreaking treatment to Netherton Syndrome patients worldwide."
Along with its ongoing research and development, Skinvisible continues to actively seek strategic partnerships with pharmaceutical and biotech companies to bring topical and transdermal Invisicare formulations to the market including the first transdermal obesity therapies and explore broader applications of its delivery platform with other small molecules.
For more information on Skinvisible Pharmaceuticals, partnerships and investment opportunities, please contact info@skinvisible.com.
About Skinvisible Pharmaceuticals, Inc.
Skinvisible Pharmaceuticals, a wholly-owned subsidiary of Skinvisible, Inc., is a pioneering research and development company specializing in licensing proprietary topical and transdermal formulations utilizing its patented polymer skin delivery system; Invisicare. This innovative technology provides life-cycle management and distinctive enhancements for both topical and transdermal delivery products. Invisicare formulated as a lotion or cream, effectively adheres active ingredients to the skin facilitating a controlled release of the active to and/or through the skin and into the blood stream over time. Skinvisible has recently developed formulations for the potential treatment of obesity, along with over forty dermatology related conditions including rare skin disorders. For further details, please visit www.skinvisible.com.
Forward-Looking Statements: This press release contains 'forward looking' statements within the meaning of Section