Skinvisible Reports Licensee Success in Netherton Syndrome Clinical Studies
Skinvisible Pharmaceuticals (OTCQB:SKVI) reports significant progress through its licensee Quoin Pharmaceuticals' advancement in Netherton Syndrome treatment. The company's proprietary Invisicare® technology and formulation, licensed to Quoin, has shown positive results in clinical studies. Key developments include FDA clearance for a 'whole body' study at Northwestern University and significant clinical improvements in both open label and pediatric studies, where subjects' conditions improved from 'severe' to 'mild' after 6 weeks of treatment.
The treatment, QRX003, has been licensed in 60 countries with studies expanding to UK, Ireland, and Saudi Arabia. Upon FDA or EU approval, Skinvisible will receive a $5 million milestone payment plus ongoing royalties from sales. No adverse events or safety concerns have been reported in the ongoing clinical studies.
Skinvisible Pharmaceuticals (OTCQB:SKVI) riporta progressi significativi grazie all'avanzamento del proprio licenziatario Quoin Pharmaceuticals nel trattamento della Sindrome di Netherton. La tecnologia e la formulazione proprietaria Invisicare®, concessa in licenza a Quoin, hanno mostrato risultati positivi negli studi clinici. I principali sviluppi includono l'approvazione da parte della FDA per uno studio su 'corpo intero' presso la Northwestern University e significativi miglioramenti clinici sia negli studi in aperto che pediatrici, dove le condizioni dei soggetti sono passate da 'severe' a 'mild' dopo 6 settimane di trattamento.
Il trattamento, QRX003, è stato concesso in licenza in 60 paesi, con studi in espansione nel Regno Unito, in Irlanda e in Arabia Saudita. Una volta ottenuta l'approvazione dalla FDA o dall'UE, Skinvisible riceverà un pagamento di milestone di 5 milioni di dollari e royalties ongoing dalle vendite. Non sono stati riportati eventi avversi o preoccupazioni per la sicurezza negli studi clinici in corso.
Skinvisible Pharmaceuticals (OTCQB:SKVI) informa sobre avances significativos gracias al avance de su licenciatario Quoin Pharmaceuticals en el tratamiento de la síndrome de Netherton. La tecnología y formulación propietaria Invisicare®, licenciada a Quoin, ha mostrado resultados positivos en estudios clínicos. Los desarrollos clave incluyen la aprobación de la FDA para un estudio de 'cuerpo completo' en la Universidad Northwestern y mejoras clínicas significativas tanto en estudios abiertos como pediátricos, donde las condiciones de los sujetos mejoraron de 'severas' a 'leves' tras 6 semanas de tratamiento.
El tratamiento, QRX003, ha sido licenciado en 60 países, con estudios en expansión hacia el Reino Unido, Irlanda y Arabia Saudita. Al obtener la aprobación de la FDA o de la UE, Skinvisible recibirá un pago por hitos de 5 millones de dólares más regalías continuas por ventas. No se han reportado eventos adversos ni preocupaciones de seguridad en los estudios clínicos en curso.
스킨비저블 제약 (OTCQB:SKVI)는 라이센스 보유사인 쿼인 제약의 네더턴 증후군 치료 분야에서의 발전을 통해 중요한 진전을 보고합니다. 회사의 독점 기술인 인비사케어(Invisicare®)와 제형이 쿼인에 라이센스되어 긍정적인 임상 연구 결과를 보였습니다. 주요 발전 사항으로는 노스웨스턴 대학교에서의 '전신' 연구에 대한 FDA 승인이 포함되며, 공개연구 및 소아 연구에서 피험자의 조건이 6주 치료 후 '중증'에서 '경증'으로 개선된 중요한 임상 개선이 있었습니다.
치료 방법 QRX003은 60개국에 라이센스가 부여되어 있으며, 연구가 영국, 아일랜드, 사우디아라비아로 확대되고 있습니다. FDA 또는 EU 승인을 받을 경우, 스킨비저블은 500만 달러의 이정표 지급과 판매로부터 지속적인 로열티를 받게 됩니다. 진행 중인 임상 연구에서 부작용이나 안전성 문제는 보고되지 않았습니다.
Skinvisible Pharmaceuticals (OTCQB:SKVI) fait rapport de progrès significatifs grâce à l'avancement de son licencié Quoin Pharmaceuticals dans le traitement du syndrome de Netherton. La technologie et la formulation propriétaires Invisicare®, concédées sous licence à Quoin, ont montré des résultats positifs dans les études cliniques. Les développements clés comprennent l'approbation de la FDA pour une étude 'corps entier' à l'Université Northwestern et des améliorations cliniques significatives tant dans les études ouvertes que pédiatriques, où l'état des sujets est passé de 'sévère' à 'léger' après 6 semaines de traitement.
Le traitement, QRX003, a été concédé en licence dans 60 pays, avec des études s'étendant au Royaume-Uni, en Irlande et en Arabie Saoudite. Après approbation par la FDA ou l'UE, Skinvisible recevra un paiement de jalon de 5 millions de dollars ainsi que des redevances continues sur les ventes. Aucun événement indésirable ou préoccupation de sécurité n'a été signalé dans les études cliniques en cours.
Skinvisible Pharmaceuticals (OTCQB:SKVI) berichtet von wichtigen Fortschritten durch den Fortschritt seines Lizenznehmers Quoin Pharmaceuticals bei der Netherton-Syndrom-Behandlung. Die proprietäre Technologie und Formulierung Invisicare®, die an Quoin lizenziert wurde, hat positive Ergebnisse in klinischen Studien gezeigt. Zu den wichtigen Entwicklungen gehört die FDA-Zulassung für eine 'Ganzkörper'-Studie an der Northwestern University sowie signifikante klinische Verbesserungen in sowohl offenen als auch pädiatrischen Studien, in denen sich die Zustände der Probanden nach 6 Wochen Behandlung von 'schwer' auf 'mild' verbesserten.
Die Behandlung QRX003 wurde in 60 Ländern lizenziert, mit Ausweitungen der Studien auf das Vereinigte Königreich, Irland und Saudi-Arabien. Nach der Genehmigung durch die FDA oder die EU wird Skinvisible eine Meilensteinzahlung von 5 Millionen US-Dollar sowie fortlaufende Lizenzgebühren aus dem Verkauf erhalten. Es wurden keine unerwünschten Ereignisse oder Sicherheitsbedenken in den laufenden klinischen Studien berichtet.
- FDA clearance obtained for 'whole body' study
- Clinical trials showed improvement from 'severe' to 'mild' after 6 weeks
- No adverse events or safety concerns reported in clinical studies
- $5 million milestone payment upon FDA/EU approval plus ongoing royalties
- Product licensed in 60 countries
- International expansion of studies to multiple countries
- None.
Insights
The latest clinical developments for Skinvisible's licensed Netherton Syndrome treatment represent a significant milestone in both therapeutic and financial terms. Netherton Syndrome, while rare, represents an untapped market with no currently approved treatments, positioning Skinvisible's licensee as a potential first-mover in this space.
The FDA clearance for "whole body" studies at Northwestern University is particularly noteworthy, as it addresses a important clinical need - Netherton Syndrome affects the entire skin surface and localized treatments would have therapeutic value. The reported improvement from "severe" to "mild" classification in just 6 weeks suggests remarkable efficacy, especially considering the chronic nature of this condition.
From a financial perspective, this progress has multiple implications:
- The potential
$5 million milestone payment upon FDA/EU approval provides near-term revenue potential - Ongoing royalties from sales across 60 licensed countries could generate substantial long-term revenue streams
- The successful validation of Invisicare technology could attract additional licensing partnerships for other indications
The clean safety profile and rapid clinical improvements observed so far suggest a favorable risk-benefit ratio, which typically streamlines the regulatory approval process. Given the orphan disease status and unmet medical need, an expedited review pathway is likely, potentially accelerating time to market.
For investors, this represents a potential inflection point for Skinvisible. Beyond the immediate Netherton Syndrome opportunity, successful clinical validation of Invisicare technology could unlock value across the company's broader pipeline, including its novel transdermal obesity therapies under development.
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
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 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby including with respect to the possible development of any such products, the acceptance of any such products in the market place, the size of any such markets, the ability of any product candidates to be approved by the U.S. Food and Drug Administration among others. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward-looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on file with the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the period ending September 30, 2024).
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Contact:
Strategic Partnerships: Doreen McMorran - doreen@invisicare.com
Corporate Inquiries: info@skinvisible.com
Website: www.skinvisible.com
SOURCE: Skinvisible, Inc.
View the original press release on ACCESS Newswire
FAQ
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