Inhibitor Therapeutics, Inc. Provides Update on its Clinical Development Plan
Inhibitor Therapeutics, Inc. (OTCQB: INTI) has provided an update on its clinical development plan for an itraconazole formulation to treat Basal Cell Carcinomas in Gorlin Syndrome patients. The company has submitted a Pre-Investigational New Drug application (PIND) to the FDA and received preliminary comments. INTI has engaged Avior Bio to develop a new proprietary formulation of itraconazole, which will be bridged to the formulation used in their completed clinical study via a pharmacokinetic study.
The completed clinical study showed promising results, with 399 out of 477 targeted tumors showing reduction, 275 tumors (57.7%) achieving a clinically meaningful reduction of 30% or greater, and 130 tumors (27.3%) resolving completely. Inhibitor aims to submit an Investigational New Drug Application (IND) to the FDA by the end of Q1 2025.
Inhibitor Therapeutics, Inc. (OTCQB: INTI) ha fornito un aggiornamento sul suo piano di sviluppo clinico per una formulazione di itraconazolo destinata a trattare i carcinomi basocellulari nei pazienti con sindrome di Gorlin. L'azienda ha presentato una domanda di Pre-Investigational New Drug (PIND) alla FDA e ha ricevuto commenti preliminari. INTI ha collaborato con Avior Bio per sviluppare una nuova formulazione proprietaria di itraconazolo, che sarà collegata alla formulazione utilizzata nel loro studio clinico completato tramite uno studio farmacocinetico.
Il studio clinico completato ha mostrato risultati promettenti, con 399 su 477 tumori mirati che hanno mostrato riduzione, 275 tumori (57,7%) hanno raggiunto una riduzione clinicamente significativa del 30% o maggiore e 130 tumori (27,3%) sono stati completamente risolti. Inhibitor punta a presentare una Domanda di Nuovo Farmaco Sperimentale (IND) alla FDA entro la fine del Q1 2025.
Inhibitor Therapeutics, Inc. (OTCQB: INTI) ha proporcionado una actualización sobre su plan de desarrollo clínico para una formulación de itraconazol destinada al tratamiento de carcinomas de células basales en pacientes con síndrome de Gorlin. La compañía ha presentado una solicitud de Pre-Investigational New Drug (PIND) a la FDA y ha recibido comentarios preliminares. INTI ha contratado a Avior Bio para desarrollar una nueva formulación propietaria de itraconazol, que se conectará a la formulación utilizada en su estudio clínico completado a través de un estudio farmacocinético.
El estudio clínico completado mostró resultados prometedores, con 399 de 477 tumores objetivo mostrando reducción, 275 tumores (57.7%) logrando una reducción clínicamente significativa del 30% o más, y 130 tumores (27.3%) resolviéndose completamente. Inhibitor tiene como objetivo presentar una Solicitud de Nuevo Medicamento en Investigación (IND) a la FDA para finales del primer trimestre de 2025.
Inhibitor Therapeutics, Inc. (OTCQB: INTI)는 고를린 증후군 환자의 기저세포암 치료를 위한 이트라코나졸 제형의 임상 개발 계획에 대한 업데이트를 제공했습니다. 이 회사는 FDA에 사전 연구 신약 신청서(PIND)를 제출하고 초기 의견을 받았습니다. INTI는 Avior Bio와 협력하여 새로운 독점 이트라코나졸 제형을 개발하고 있으며, 이는 완료된 임상 연구에서 사용된 제형과 약리학적 연구를 통해 연결될 것입니다.
완료된 임상 연구는 477개의 목표 종양 중 399개에서 크기 감소를 보여주는 유망한 결과를 보였습니다. 275개의 종양(57.7%)이 30% 이상의 임상적으로 의미 있는 감소를 달성했으며, 130개의 종양(27.3%)이 완전히 해결되었습니다. Inhibitor는 2025년 1분기 말까지 FDA에 임상신약신청서(IND)를 제출할 계획입니다.
Inhibitor Therapeutics, Inc. (OTCQB: INTI) a fourni une mise à jour sur son plan de développement clinique pour une formulation d'itraconazole destinée à traiter les carcinomes basocellulaires chez les patients atteints du syndrome de Gorlin. L'entreprise a soumis une demande de Pre-Investigational New Drug (PIND) à la FDA et a reçu des commentaires préliminaires. INTI a engagé Avior Bio pour développer une nouvelle formulation propriétaire d'itraconazole, qui sera reliée à la formulation utilisée dans leur étude clinique terminée via une étude pharmacocinétique.
Cette étude clinique achevée a montré des résultats prometteurs, avec 399 des 477 tumeurs ciblées montrant une réduction, 275 tumeurs (57,7%) atteignant une réduction cliniquement significative de 30 % ou plus, et 130 tumeurs (27,3%) résolvant complètement. Inhibitor vise à soumettre une demande de nouveau médicament à la recherche (IND) à la FDA d'ici la fin du premier trimestre 2025.
Inhibitor Therapeutics, Inc. (OTCQB: INTI) hat ein Update zu seinem klinischen Entwicklungsplan für eine Itraconazol-Formulierung zur Behandlung von Basalzellkarzinomen bei Gorlin-Syndrom-Patienten bereitgestellt. Das Unternehmen hat einen Antrag auf Pre-Investigational New Drug (PIND) bei der FDA eingereicht und erste Kommentare erhalten. INTI hat Avior Bio beauftragt, eine neue proprietäre Itraconazol-Formulierung zu entwickeln, die über eine pharmakokinetische Studie mit der im abgeschlossenen klinischen Studium verwendeten Formulierung verbunden wird.
Die abgeschlossene klinische Studie zeigte vielversprechende Ergebnisse, wobei 399 von 477 anvisierten Tumoren eine Reduktion zeigten, 275 Tumoren (57,7%) eine klinisch relevante Reduktion von 30% oder mehr erreichten und 130 Tumoren (27,3%) vollständig verschwanden. Inhibitor plant, bis Ende Q1 2025 einen Antrag auf einen investigationalen neuen Arzneimittelantrag (IND) bei der FDA einzureichen.
- Promising clinical study results with 57.7% of tumors showing significant reduction
- 27.3% of targeted tumors resolved completely in the clinical study
- FDA has provided preliminary comments and guidance for IND preparation
- Development of a new proprietary/patentable formulation of itraconazole
- Planned submission of IND to FDA by end of Q1 2025
- Potential delays in regulatory approval process
- Uncertainty in FDA's final acceptance of the new drug application
- Possible competition in the Basal Cell Carcinoma treatment market
TAMPA, Fla., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Inhibitor Therapeutics, Inc. ("Inhibitor") (OTCQB: INTI) today provided an update on development efforts for its itraconazole formulation for the treatment of Basal Cell Carcinomas in patients with Basal Cell Carcinoma Nevus Syndrome, otherwise known as Gorlin Syndrome. Inhibitor has allied with The Gorlin Syndrome Alliance and sought supportive guidance from the accomplished and highly-experienced members of its Scientific Advisory Board in efforts to pursue an expeditious path to acceptance by the U.S. Food and Drug Administration (FDA).
Inhibitor has submitted a Pre-Investigational New Drug application (PIND) which has been reviewed by the FDA’s Division of Dermatology and Dentistry and will have input from the Division of Oncology 3 where necessary. INTI has received preliminary comments from the FDA with guidance in preparation for an Investigation New Drug Application (IND)
Inhibitor has engaged Avior Bio for the development of a new proprietary/patentable formulation of itraconazole that will be bridged to the formulation used within Inhibitor’s completed clinical study and to the generic formulation of itraconazole via a pharmacokinetic (PK) study. Itraconazole has a well understood safety profile and, based upon the data developed in the completed clinical study, demonstrated clinically meaningful efficacy in the treatment of Basal Cell Carcinomas in patients with Gorlin Syndrome.
Of the 477 targeted tumors studied throughout the clinical study, it was reported that 399 had a reduction of any size, 64 had no change and 14 increased in size. A clinically meaningful reduction of size of
Inhibitor’s plan for continued development of its itraconazole therapeutic include i) completing the new proprietary formulation inclusive of patent creation; ii) conducting/compiling results of the bridging PK study; and iii) preparing and submitting its IND. Inhibitor anticipates that it will be prepared to submit this IND to the FDA for their review and guidance by the end of Q1 2025.
For more information about Inhibitor and our mission please visit us on our website (www.inhibitortx.com) and for any further or specific questions you may have please visit our contact us page, submit your details/query, and a representative will be happy to respond.
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FAQ
What is Inhibitor Therapeutics developing for Gorlin Syndrome patients?
What were the results of INTI's completed clinical study for Basal Cell Carcinomas?
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