Quoin Pharmaceuticals Initiates Clinical Testing of Lead Product in Pediatric Netherton Syndrome Patient
Quoin Pharmaceuticals (NASDAQ: QNRX) has begun testing QRX003 in a pediatric patient with Netherton Syndrome (NS) at Children's Health Ireland in Dublin, led by Dr. Alan Irvine. The company plans to expand testing to include three additional pediatric patients in Spain. QRX003 is currently being evaluated in two late-stage clinical trials, with promising results showing improvement across multiple endpoints and no treatment-related adverse events. The company is expanding its clinical sites beyond the existing five U.S. locations, with new sites planned in Saudi Arabia and two in the United Kingdom.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha iniziato a testare QRX003 in un paziente pediatricoa con syndrome di Netherton (NS) presso il Children's Health Ireland a Dublino, sotto la guida del Dr. Alan Irvine. L'azienda prevede di espandere i test per includere tre ulteriori pazienti pediatrici in Spagna. QRX003 è attualmente in fase di valutazione in due trial clinici avanzati, con risultati promettenti che mostrano miglioramenti su molteplici parametri e senza eventi avversi correlati al trattamento. L'azienda sta ampliando i suoi siti clinici oltre i cinque già esistenti negli Stati Uniti, con nuovi siti programmati in Arabia Saudita e due nel Regno Unito.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha comenzado a probar QRX003 en un paciente pediátrico con síndrome de Netherton (NS) en Children's Health Ireland en Dublín, dirigido por el Dr. Alan Irvine. La compañía planea ampliar las pruebas para incluir tres pacientes pediátricos adicionales en España. QRX003 se está evaluando actualmente en dos ensayos clínicos avanzados, con resultados prometedores que muestran mejoría en varios criterios y sin eventos adversos relacionados con el tratamiento. La empresa está expandiendo sus sitios clínicos más allá de las cinco ubicaciones existentes en EE. UU., con nuevos lugares planeados en Arabia Saudita y dos en el Reino Unido.
퀘인 제약 (NASDAQ: QNRX)는 더블린의 아일랜드 아동 건강 병원에서 앨런 어빈 박사가 주도하는 네더튼 증후군 (NS) 환아를 대상으로 QRX003의 시험을 시작했습니다. 회사는 스페인에서 세 명의 추가 아동 환자를 포함하는 시험을 확장할 계획입니다. QRX003은 현재 두 개의 후기 임상 시험에서 평가되고 있으며, 여러 지표에서 개선을 보이고 치료와 관련된 부작용이 없는 유망한 결과를 보여주고 있습니다. 이 회사는 기존의 미국 내 다섯 개 위치를 넘어 임상 사이트를 확장하고 있으며, 사우디 아라비아와 영국에 두 개의 새로운 사이트를 계획하고 있습니다.
Quoin Pharmaceuticals (NASDAQ: QNRX) a commencé à tester QRX003 chez un patient pédiatrique atteint du syndrome de Netherton (NS) à l'hôpital Children's Health Ireland à Dublin, sous la direction du Dr Alan Irvine. L'entreprise prévoit d'élargir les tests pour inclure trois patients pédiatriques supplémentaires en Espagne. QRX003 est actuellement évalué dans deux essais cliniques de phase avancée, avec des résultats prometteurs montrant une amélioration sur plusieurs critères et sans événements indésirables liés au traitement. L'entreprise élargit ses sites cliniques au-delà des cinq sites existants aux États-Unis, avec de nouveaux sites prévus en Arabie Saoudite et deux au Royaume-Uni.
Quoin Pharmaceuticals (NASDAQ: QNRX) hat mit der Testung von QRX003 bei einem pädiatrischen Patienten mit Netherton-Syndrom (NS) im Children's Health Ireland in Dublin unter der Leitung von Dr. Alan Irvine begonnen. Das Unternehmen plant, die Tests auf drei weitere pädiatrische Patienten in Spanien auszudehnen. QRX003 wird derzeit in zwei späten klinischen Studien bewertet, die vielversprechende Ergebnisse zeigen und in denen Verbesserungen bei mehreren Endpunkten und keine behandlungsbedingten unerwünschten Ereignisse festgestellt wurden. Das Unternehmen erweitert seine klinischen Standorte über die bereits bestehenden fünf Standorte in den USA hinaus, mit neuen Standorten, die in Saudi-Arabien und zwei im Vereinigten Königreich geplant sind.
- Expansion of clinical testing to pediatric patients, broadening the potential market
- Promising clinical data showing improvement across multiple endpoints
- No treatment-related adverse events reported in current trials
- Geographic expansion of clinical sites to Saudi Arabia and UK
- Testing conducted by renowned expert in the field
- No approved treatment or cure currently exists for Netherton Syndrome
- Product still in clinical testing phase with no guaranteed approval
Insights
The initiation of pediatric testing for QRX003 represents a significant milestone in Quoin's clinical development program. The expansion to treat children with Netherton Syndrome (NS) could substantially broaden the potential patient population, particularly important given there are no approved treatments for this rare genetic disease.
The data collection from pediatric patients across multiple international sites (Ireland, Spain) alongside existing adult trials demonstrates a comprehensive clinical strategy. The company's current positive safety profile in adults, with no treatment-related adverse events, is particularly encouraging for pediatric applications. The involvement of Dr. Alan Irvine, a leading authority in dermatology, adds credibility to this expansion.
With multiple trial sites across the US, Saudi Arabia and planned UK expansions, Quoin is building a robust global presence that could accelerate patient recruitment and strengthen future commercialization potential.
- Clinical Assessment Is Being Performed on a Pediatric Patient at Children’s Health Ireland in Dublin
- First Evaluation of QRX003 in a Pediatric Patient
- Second Clinical Site to Open in Spain with Potentially Three Additional Pediatric Netherton Patients
ASHBURN, Va., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a clinical-stage specialty pharmaceutical company focused on novel treatments for rare and orphan diseases, today announced that it has initiated the testing of the safety and efficacy of QRX003 in a young child with Netherton Syndrome (NS), a rare inherited genetic disease. There is currently no approved treatment for NS and no cure.
The clinical assessment is being led by Dr. Alan Irvine, a consultant dermatologist at Children’s Health Ireland and professor of dermatology at Trinity College Dublin. Dr. Irvine is president of the International Eczema Council and an elected member of the Royal Irish Academy. He has published over 250 peer-reviewed papers in high-impact journals, including many on epithelial genetics.
“We are pleased to announce this latest initiative for Quoin as we strive to generate the broadest and most diverse data set possible for QRX003 in Netherton Syndrome patients. Furthermore, we are delighted that Professor Irvine, one of the world’s leading researchers in this disease, has agreed to perform this assessment of QRX003. Currently, we are testing patients aged 14 years and up in our two ongoing clinical studies and we hope that data generated by Professor Irvine will facilitate lowering the eligibility age further. In addition, we look forward to broadening the scope of this clinical assessment to include three additional pediatric subjects in Spain,” said Dr. Michael Myers, Quoin CEO.
QRX003 is Quoin’s most advanced pipeline product and is currently being evaluated in two late-stage clinical trials as a potential treatment for NS under an open Investigational New Drug application with the U.S. Food and Drug Administration. Clinical data generated to date for QRX003 in NS patients has been promising with all evaluable subjects demonstrating improvement across a number of endpoints with no treatment-related adverse events recorded. In addition to the five open clinical sites in the United States, a sixth site is opening in Saudi Arabia. On October 22, Quoin also announced the planned opening of two additional clinical sites in the United Kingdom, each of which has a cohort of patients potentially eligible for recruitment.
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 an emerging 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, go to: www.quoinpharma.com.
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, -a second clinical site to open in Spain with potentially three additional pediatric Netherton patients, the Company striving to generate the broadest and most diverse data set possible for QRX003 in Netherton Syndrome patients, the Company hoping that data generated by Professor Irvine will facilitate the Company lowering the eligibility age further, the Company opening a sixth site in Saudi Arabia, a planned opening of two additional clinical sites in the United Kingdom (each of which has a cohort of patients potentially eligible for recruitment), 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, the clinical study may not be successful may not generate data which is sufficiently robust and comprehensive to support lowering the eligibility age further, the Company’s ability to open the planned sites as and when planned and 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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