Quoin Pharmaceuticals Files U.S. Patent Application for Novel Topical Formulations to Treat Netherton Syndrome and Other Skin Diseases
Quoin Pharmaceuticals (NASDAQ: QNRX) has filed a U.S. patent application for novel topical formulations targeting multiple skin diseases, including Netherton Syndrome (NS). The company's lead product, QRX003, is currently undergoing testing in four clinical trials, with three conducted under FDA's Investigational New Drug (IND) application.
The patent application extends to other conditions including Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, and Severe Atopic Dermatitis. If granted, this would be Quoin's third patent for Netherton Syndrome, providing protection until 2045. The company has reported positive initial clinical data from two open-label studies and is conducting a pediatric NS patient study at Dublin's Children's Hospital, with plans to expand to Spain, UK, and other countries.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha presentato una domanda di brevetto negli Stati Uniti per nuove formulazioni topiche mirate a diverse malattie della pelle, incluso la Sindrome di Netherton (NS). Il prodotto di punta dell'azienda, QRX003, è attualmente in fase di sperimentazione in quattro studi clinici, di cui tre condotti sotto la domanda di Nuovo Farmaco Investigativo (IND) della FDA.
La domanda di brevetto si estende ad altre condizioni, tra cui la Sindrome della Pelle Desquamante, la Sindrome di SAM, la Cheratodermia Palmoplantare e la Dermatite Atopica Grave. Se concessa, questo sarebbe il terzo brevetto di Quoin per la Sindrome di Netherton, garantendo protezione fino al 2045. L'azienda ha riportato dati clinici iniziali positivi da due studi open-label e sta conducendo uno studio su pazienti pediatrici affetti da NS presso l'Ospedale dei Bambini di Dublino, con piani di espansione in Spagna, Regno Unito e altri paesi.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha presentado una solicitud de patente en EE. UU. para nuevas formulaciones tópicas dirigidas a múltiples enfermedades de la piel, incluida la Síndrome de Netherton (NS). El producto líder de la compañía, QRX003, se encuentra actualmente en pruebas en cuatro ensayos clínicos, de los cuales tres se llevan a cabo bajo la solicitud de Nuevo Medicamento Investigacional (IND) de la FDA.
La solicitud de patente se extiende a otras condiciones, incluyendo el Síndrome de Piel Descamativa, el Síndrome de SAM, la Queratosis Palmoplantar y la Dermatitis Atópica Severa. Si se concede, esta sería la tercera patente de Quoin para la Síndrome de Netherton, brindando protección hasta 2045. La compañía ha reportado datos clínicos iniciales positivos de dos estudios abiertos y está llevando a cabo un estudio en pacientes pediátricos con NS en el Hospital Infantil de Dublín, con planes de expansión a España, Reino Unido y otros países.
퀘인 제약 (NASDAQ: QNRX)은 여러 피부 질환을 대상으로 하는 새로운 국소 제형에 대한 미국 특허 출원을 했습니다. 여기에는 네서턴 증후군 (NS)이 포함됩니다. 회사의 주요 제품인 QRX003은 현재 FDA의 임상 시험 (IND) 신청 하에 세 가지를 포함한 네 개의 임상 시험에서 테스트되고 있습니다.
특허 출원은 벗겨지는 피부 증후군, SAM 증후군, 손바닥 발바닥 각화증 및 심한 아토피 피부염을 포함한 다른 질환으로 확장됩니다. 만약 특허가 승인된다면, 이는 퀘인의 네서턴 증후군에 대한 세 번째 특허가 되어 2045년까지 보호를 제공할 것입니다. 회사는 두 개의 공개 연구에서 긍정적인 초기 임상 데이터를 보고했으며, 더블린 아동 병원에서 NS 환자에 대한 소아 연구를 진행하고 있으며, 스페인, 영국 및 기타 국가로의 확장을 계획하고 있습니다.
Quoin Pharmaceuticals (NASDAQ: QNRX) a déposé une demande de brevet aux États-Unis pour de nouvelles formulations topiques ciblant plusieurs maladies de la peau, y compris le syndrome de Netherton (NS). Le produit phare de l'entreprise, QRX003, est actuellement en phase d'essai dans quatre études cliniques, dont trois sont menées sous la demande de Nouveau Médicament Expérimental (IND) de la FDA.
La demande de brevet s'étend à d'autres conditions, y compris le syndrome de peau desquamante, le syndrome de SAM, la kératodermie palmoplantaire et la dermatite atopique sévère. Si elle est accordée, ce serait le troisième brevet de Quoin pour le syndrome de Netherton, offrant une protection jusqu'en 2045. L'entreprise a rapporté des données cliniques initiales positives provenant de deux études ouvertes et mène une étude sur des patients pédiatriques atteints de NS à l'hôpital pour enfants de Dublin, avec des plans d'expansion en Espagne, au Royaume-Uni et dans d'autres pays.
Quoin Pharmaceuticals (NASDAQ: QNRX) hat einen US-Patentantrag für neuartige topische Formulierungen eingereicht, die auf mehrere Hautkrankheiten abzielen, einschließlich Netherton-Syndrom (NS). Das Hauptprodukt des Unternehmens, QRX003, wird derzeit in vier klinischen Studien getestet, von denen drei unter dem Investigational New Drug (IND)-Antrag der FDA durchgeführt werden.
Der Patentantrag erstreckt sich auch auf andere Erkrankungen, einschließlich des Peeling-Skin-Syndroms, des SAM-Syndroms, der palmoplantarer Keratodermie und der schweren atopischen Dermatitis. Sollte er gewährt werden, wäre dies das dritte Patent von Quoin für das Netherton-Syndrom und würde bis 2045 Schutz bieten. Das Unternehmen hat positive erste klinische Daten aus zwei offenen Studien berichtet und führt eine Studie an pädiatrischen NS-Patienten im Kinderkrankenhaus Dublin durch, mit Plänen zur Expansion nach Spanien, Großbritannien und anderen Ländern.
- Patent application could extend protection for QRX003 until 2045
- Positive initial clinical data reported from two open-label studies
- Only company actively recruiting and testing subjects in multiple NS trials under open IND
- Expanding pediatric trials internationally
- No FDA approved treatments exist for target conditions yet
- Multiple clinical trials still ongoing without final results
Insights
Quoin's new patent application represents a strategic expansion of their intellectual property portfolio for rare skin disease treatments. If granted, this would be their third patent for Netherton Syndrome (NS) treatments, extending protection for QRX003 until 2045. This timeline is particularly significant, as it would secure 20+ years of market exclusivity for their lead asset.
What's most notable is how Quoin is building a multi-layered IP strategy. By filing applications covering both their lead indication (NS) and several additional rare skin conditions (Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, and Severe Atopic Dermatitis), they're creating a protective moat around their topical formulation technology across multiple potential revenue streams.
The timing aligns strategically with their clinical progress, as they're concurrently advancing four NS trials. Two have already yielded positive initial data, though specifics on efficacy metrics weren't provided. Their first-mover advantage in an orphan disease space with no FDA-approved treatments is meaningful - orphan drug designation typically provides additional exclusivity periods and potential regulatory benefits.
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- Target Indications Also Include Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma and Severe Atopic Dermatitis
- Third Quoin Patent Application for Netherton Syndrome
- If Granted Company Would have Patent Protection for QRX003 for Netherton Syndrome Until 2045
ASHBURN, Va., March 25, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late-stage clinical, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announced it has filed a U.S. patent application for novel topical formulations to treat a number of skin diseases, including Netherton Syndrome (NS). Quoin’s lead product, QRX003, is currently being tested in four Netherton Syndrome clinical trials. Three of these trials are being conducted under Quoin’s open Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). QRX003 is also currently being tested in a pediatric NS patient at the Children’s Hospital in Dublin, Ireland and the Company intends to expand this study to include additional children with NS in Spain, the United Kingdom and potentially other countries. The Company has recently reported positive initial clinical data from the two open label studies for which data is available. This patent application also includes Peeling Skin Syndrome for which Quoin has an ongoing Investigator Clinical Study in a pediatric patient in New Zealand. There are currently no FDA approved treatments for either Netherton Syndrome or Peeling Skin Syndrome.
“While we are fully focused on completing clinical testing for QRX003 in NS, we are also taking multiple steps to ensure that we have the broadest and most extensive patent protection around the product for this disease as well for other rare skin disease applications that we are pursuing or intend to pursue. If granted, this application would provide broad patent protection for our product until 2045.” said Dr. Michael Myers, Chief Executive Officer of Quoin.
Quoin is currently enrolling patients in three clinical trials being conducted under its open Investigational New Drug (IND) application, evaluating its QRX003 topical lotion as a potential treatment for Netherton Syndrome as well as in an Investigator led pediatric study. To date, Quoin remains the only company actively recruiting and testing subjects in multiple NS clinical trials that are being conducted under an open IND.
To find out more about Quoin’s clinical studies relating to Netherton Syndrome, please visit http://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 five products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, go to: www.quoinpharma.com.
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. 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 Company obtaining patent protection for its Netherton Syndrome product until 2045; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; the potential efficacy of QRX003 as a treatment for Netherton Syndrome; the progress or success of Quoin’s ongoing clinical trials; 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 protect its assets with the new patent applications; the Company’s ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 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
FAQ
What conditions will Quoin Pharmaceuticals' new patent application cover for QNRX?
How many clinical trials is QNRX currently conducting for QRX003 in Netherton Syndrome?
When will QNRX's patent protection for QRX003 in Netherton Syndrome expire if granted?
What is the current status of QRX003's clinical trials for QNRX?
