Quoin Pharmaceuticals Announces Further International Expansion of Ongoing Clinical Trials for Netherton Syndrome
Quoin Pharmaceuticals (NASDAQ: QNRX) has announced the expansion of its ongoing Netherton Syndrome (NS) clinical trials to include two additional sites in the United Kingdom. The new sites are Great Ormond Street Hospital and St. Thomas' Hospital in London, both recognized as centers of excellence for treating NS patients. A Principal Investigator has been appointed, and a Clinical Research Organization has been engaged for the UK studies.
These sites, along with the previously announced site in Saudi Arabia, will operate under Quoin's open Investigational New Drug (IND) application with the US FDA. The company is also preparing to open additional sites in Western and Eastern European countries with available NS patient cohorts.
Quoin is currently conducting two clinical trials evaluating QRX003, a topical lotion, for the treatment of Netherton Syndrome. The company aims to complete enrollment in both studies rapidly to potentially deliver the first approved treatment for this rare, inherited genetic disease.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha annunciato l'espansione dei suoi attuali trial clinici sul Sindrome di Netherton (NS) per includere due ulteriori siti nel Regno Unito. I nuovi siti sono il Great Ormond Street Hospital e il St. Thomas' Hospital a Londra, entrambi riconosciuti come centri di eccellenza per il trattamento dei pazienti con NS. È stato nominato un Investigatore Principale e un'Organizzazione di Ricerca Clinica è stata ingaggiata per gli studi nel Regno Unito.
Questi siti, insieme al sito precedentemente annunciato in Arabia Saudita, opereranno sotto l'applicazione aperta di Nuovo Farmaco Investigativo (IND) di Quoin con la FDA degli Stati Uniti. L'azienda sta anche preparando l'apertura di ulteriori siti in paesi dell'Europa occidentale e orientale con coorti di pazienti NS disponibili.
Quoin sta attualmente conducendo due trial clinici che valutano QRX003, una lozione topica, per il trattamento della Sindrome di Netherton. L'azienda mira a completare rapidamente l'arruolamento in entrambi gli studi per fornire potenzialmente il primo trattamento approvato per questa rara malattia genetica ereditaria.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha anunciado la expansión de sus ensayos clínicos en curso sobre el Síndrome de Netherton (NS) para incluir dos sitios adicionales en el Reino Unido. Los nuevos sitios son el Great Ormond Street Hospital y el St. Thomas' Hospital en Londres, ambos reconocidos como centros de excelencia para tratar a pacientes con NS. Se ha designado un Investigador Principal y se ha contratado a una Organización de Investigación Clínica para los estudios en el Reino Unido.
Estos sitios, junto con el sitio previamente anunciado en Arabia Saudita, operarán bajo la solicitud de Nuevo Medicamento Investigacional (IND) abierta de Quoin con la FDA de EE. UU. La compañía también se está preparando para abrir sitios adicionales en países de Europa occidental y oriental con cohortes de pacientes de NS disponibles.
Quoin está llevando a cabo actualmente dos ensayos clínicos que evalúan QRX003, una loción tópica, para el tratamiento del Síndrome de Netherton. La empresa espera completar rápidamente la inscripción en ambos estudios para potencialmente ofrecer el primer tratamiento aprobado para esta rara enfermedad genética hereditaria.
Quoin Pharmaceuticals (NASDAQ: QNRX)는 네더튼 증후군(NS)에 대한 진행 중인 임상 시험의 영국 내 두 개 추가 사이트 확장을 발표했습니다. 새로운 사이트는 런던의 그레이트 오르몬드 스트리트 병원과 세인트 토마스 병원으로, 두 곳 모두 NS 환자 치료를 위한 우수 센터로 인정받고 있습니다. 주요 연구자가 임명되었으며, 영국 연구를 위한 임상 연구 기관이 참여하게 됩니다.
이 사이트들은 사우디아라비아에 이전에 발표된 사이트와 함께 Quoin의 미국 FDA에 대한 개방형 신약 임상 신청(IND) 아래 운영됩니다. 회사는 또한 서유럽 및 동유럽 국가들에서 NS 환자 집단이 있는 추가 사이트를 열 준비를 하고 있습니다.
Quoin은 현재 QRX003, 국소 로션을 네더튼 증후군 치료를 위해 평가하는 두 가지 임상 시험을 진행 중입니다. 이 회사는 두 연구에서 신속하게 등록을 완료하여 이 희귀 유전 질환에 대한 최초의 승인된 치료제를 제공할 수 있기를 희망하고 있습니다.
Quoin Pharmaceuticals (NASDAQ: QNRX) a annoncé l'extension de ses essais cliniques en cours sur le Syndrome de Netherton (NS) pour inclure deux sites supplémentaires au Royaume-Uni. Les nouveaux sites sont le Great Ormond Street Hospital et le St. Thomas' Hospital à Londres, tous deux reconnus comme des centres d'excellence pour le traitement des patients atteints de NS. Un Investigateur Principal a été nommé et une Organisation de Recherche Clinique a été engagée pour les études au Royaume-Uni.
Ces sites, ainsi que le site précédemment annoncé en Arabie Saoudite, fonctionneront sous la demande ouverte de Nouveau Médicament Investigational (IND) de Quoin auprès de la FDA américaine. L'entreprise prévoit également d'ouvrir d'autres sites dans des pays d'Europe de l'Ouest et de l'Est avec des cohortes de patients NS disponibles.
Quoin mène actuellement deux essais cliniques évaluant QRX003, une lotion topique, pour le traitement du Syndrome de Netherton. L'entreprise vise à compléter rapidement l'inscription dans les deux études afin de potentiellement offrir le premier traitement approuvé pour cette maladie génétique rare et héréditaire.
Quoin Pharmaceuticals (NASDAQ: QNRX) hat die Erweiterung seiner laufenden klinischen Studien zur Netherton-Syndrom (NS) bekannt gegeben, um zwei zusätzliche Standorte im Vereinigten Königreich einzuschließen. Die neuen Standorte sind das Great Ormond Street Hospital und das St. Thomas' Hospital in London, die beide als Exzellenzzentren für die Behandlung von NS-Patienten anerkannt sind. Ein Hauptuntersuchungsleiter wurde ernannt, und eine Klinische Forschungsorganisation wurde für die Studien im Vereinigten Königreich beauftragt.
Diese Standorte, zusammen mit dem zuvor angekündigten Standort in Saudi-Arabien, werden unter Quoins offener Antragstellung für ein neues Prüfmedikament (IND) bei der US FDA betrieben. Das Unternehmen plant auch die Eröffnung weiterer Standorte in Westeuropäischen und Osteuropäischen Ländern mit verfügbaren NS-Patientenkohorten.
Quoin führt derzeit zwei klinische Studien durch, in denen QRX003, eine topische Lotion, zur Behandlung des Netherton-Syndroms bewertet wird. Das Unternehmen zielt darauf ab, die Patientenrekrutierung in beiden Studien schnell abzuschließen, um potenziell die erste zugelassene Behandlung gegen diese seltene, erbliche genetische Erkrankung anzubieten.
- Expansion of clinical trials to two prestigious UK hospitals, potentially accelerating patient recruitment
- Appointment of Principal Investigator and engagement of Clinical Research Organization for UK studies
- Plans for further expansion into Western and Eastern European countries with available NS patient cohorts
- Progress towards potentially delivering the first approved treatment for Netherton Syndrome
- None.
Insights
The expansion of Quoin Pharmaceuticals' clinical trials for Netherton Syndrome (NS) to include two prestigious UK sites is a positive development for the company's research efforts. Great Ormond Street Hospital and St. Thomas' Hospital are recognized centers of excellence, which lends credibility to the study and may facilitate patient recruitment.
The appointment of a Principal Investigator and engagement of a Clinical Research Organization in the UK demonstrates progress in trial infrastructure. This expansion, along with the previously announced Saudi Arabian site and potential additional sites in Western and Eastern Europe, suggests a strategic approach to accelerate enrollment.
However, investors should note that while this expansion is promising, it does not guarantee successful trial outcomes or regulatory approval. The lack of specific timelines or enrollment targets in the announcement leaves some uncertainty about the study's progress and potential completion date.
For a company with a market cap of just
Two Additional Clinical Sites to be Opened in the United Kingdom
Both Sites are Recognized Centers of Excellence for Netherton Syndrome in the UK.
Principal Investigator has Been Appointed and a Clinical Research Organization Has Been Engaged
Additional Sites in other Western European Countries are being Finalized
ASHBURN, Va., Oct. 22, 2024 (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 the further expansion of its on-going Netherton Syndrome (NS) clinical studies to include two additional international sites in the United Kingdom (UK). These sites, Great Ormond Street Hospital and St. Thomas’ Hospital, both in London, are recognized centers of excellence for treating Netherton Syndrome patients in the UK. Both sites have available cohorts of patients potentially eligible to participate in Quoin’s studies. A Principal Investigator (PI) for the UK studies has been appointed and a Clinical Research Organization has been engaged.
These clinical sites, as well as the previously announced site in Saudi Arabia, will operate under the auspices of Quoin’s open Investigational New Drug (IND) application with the US Food and Drug Administration. Quoin is also in advanced stage of preparation for the opening of additional sites in several other Western European countries and is concluding a feasibility study in multiple Eastern European countries with both territories having available cohorts of patients with NS.
Quoin CEO, Dr. Michael Myers, said, “We are very pleased to announce yet another exciting development for our ongoing clinical studies. This further international expansion into two highly renowned clinical centers in the United Kingdom, coupled with our intent to open additional sites in other Western European countries as well as in Eastern Europe, underscores our determination and commitment to complete enrollment into both studies as rapidly as possible with a view to potentially delivering the first approved treatment to this underserved patient population.”
Quoin is conducting two ongoing clinical trials evaluating QRX003, a topical lotion, for the treatment of Netherton Syndrome, a rare, inherited genetic disease. For more information about the 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 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, 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, statements relating to two clinical sites to be opened in the United Kingdom; intent to open additional sites in Western European countries as well as in Eastern Europe, Company’s determination and commitment to complete enrollment into both studies as rapidly as possible with a view to potentially delivering the first approved treatment to this underserved patient population, and the Company’s five 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 open the sites in the United Kingdom, Western Europe and Eastern Europe as and when planned, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome, the preclinical and clinical studies of the Company’s product candidates may not be successful and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that the Company filed with the SEC and the Company’s subsequent filings with the SEC on Forms 10-Q and 8-K. 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:
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
FAQ
What new clinical sites has Quoin Pharmaceuticals (QNRX) added for its Netherton Syndrome trials?
How many clinical trials is Quoin Pharmaceuticals (QNRX) currently conducting for Netherton Syndrome?
What is the status of Quoin Pharmaceuticals' (QNRX) expansion into other European countries?
What is the potential significance of Quoin Pharmaceuticals' (QNRX) Netherton Syndrome treatment?
