BioNxt Reports Sublingual Cladribine Multiple Sclerosis Drug Milestones Including Large-Animal Study for Validation and Dosing Optimization
BioNxt Solutions (OTCQB:BNXTF) has achieved significant milestones in its Cladribine sublingual thin-film drug reformulation program (BNT23001) for multiple sclerosis treatment. The company has completed key technology transfers to its European CDMO and ordered the active pharmaceutical ingredient for pilot batch production.
The company is preparing for a large-animal bioavailability study in October 2025, using pigs to validate and optimize dosing. This study will serve as the final preclinical validation step before advancing to human trials. BioNxt plans to conduct its first-in-human clinical pilot study in Q1 2026, marking a significant milestone in the development of its Cladribine sublingual reformulation.
The program aims to improve patient outcomes through enhanced pharmacokinetics and easier administration methods, targeting the high-value pharmaceutical market for neurological disorders.
BioNxt Solutions (OTCQB: BNXTF) ha raggiunto importanti traguardi nel suo programma di riformulazione del farmaco a rilascio sublinguale di Cladribina (BNT23001) per il trattamento della sclerosi multipla. L'azienda ha completato trasferimenti tecnologici chiave al suo europeo CDMO e ha ordinato l’ingrediente attivo per la produzione del lotto pilota.
L’azienda si sta preparando per uno studio di biodisponibilità su grandi animali nell’ottobre 2025, utilizzando maiali per validare e ottimizzare il dosaggio. Questo studio costituirà l’ultimo passaggio di convalida preclinica prima di procedere agli studi sull’uomo. BioNxt prevede di condurre il primo studio clinico pilota nell’uomo nel primo trimestre del 2026, segnando una tappa significativa nello sviluppo della sua riformulazione sublinguale di Cladribina.
Il programma mira a migliorare gli esiti dei pazienti tramite una farmacocinetica potenziata e metodi di somministrazione più semplici, rivolgendosi al mercato farmacologico ad alto valore per i disturbi neurologici.
BioNxt Solutions (OTCQB: BNXTF) ha logrado hitos significativos en su programa de reformulación del fármaco en película delgada sublingual de cladribina (BNT23001) para el tratamiento de la esclerosis múltiple. La empresa ha completado transferencias tecnológicas clave a su CDMO europeo y ha pedido el ingrediente activo para la producción del lote piloto.
La empresa se está preparando para un estudio de biodisponibilidad en grandes animales en octubre de 2025, utilizando cerdos para validar y optimizar la dosificación. Este estudio servirá como último paso de validación preclínica antes de avanzar a ensayos en humanos. BioNxt planea realizar su primer estudio clínico piloto en humanos en el primer trimestre de 2026, marcando un hito significativo en el desarrollo de su reformulación sublingual de cladribina.
El programa tiene como objetivo mejorar los resultados de los pacientes mediante una farmacocinética mejorada y métodos de administración más simples, orientados al mercado farmacéutico de alto valor para trastornos neurológicos.
BioNxt Solutions (OTCQB: BNXTF)는 다클라드리빈의 설하형 박막 제제(BNT23001) 재구성 프로그램에서 다수의 이정표를 달성했습니다. 이 회사는 유럽 CDMO에게 주요 기술 이전을 완료했고 파일럿 배치 생산을 위한 활성 의약품 원료를 주문했습니다.
회사는 2025년 10월에 대동물 생체이용도 연구를 준비 중이며, 돼지를 사용해 용량을 검증하고 최적화할 예정입니다. 이 연구는 인간 임상에 앞서 마지막 비임상 검증 단계가 될 것입니다. BioNxt는 2026년 1분기 인간 대상 최초의 임상 파일럿 연구를 수행할 계획이며, 이는 클라드리빈 설하형 재구성 개발의 중요한 이정표가 될 것입니다.
이 프로그램의 목표는 약동학을 개선하고 더 간편한 투여 방법을 통해 신경계 질환에 대한 고부가가치 제약 시장을 목표로 환자 결과를 향상시키는 것입니다.
BioNxt Solutions (OTCQB: BNXTF) a franchi des étapes importantes dans son programme de reformulation sublinguale en film mince de la cladribine (BNT23001) pour le traitement de la sclérose en plaques. L’entreprise a terminé des transferts technologiques clés vers son CDMO européen et a commandé l’ingrédient actif pour la production pilote.
L’entreprise se prépare à une étude de biodisponibilité chez le grand animal en octobre 2025, utilisant des cochons pour valider et optimiser le dosage. Cette étude servira de dernière étape de validation préclinique avant de passer aux essais sur l’homme. BioNxt prévoit de réaliser son premier essai clinique pilote chez l’homme au premier trimestre 2026, marquant une étape importante dans le développement de sa reformulation sublinguale de la cladribine.
Le programme vise à améliorer les résultats des patients grâce à une pharmacocinétique améliorée et des méthodes d’administration plus simples, ciblant le marché pharmaceutique à forte valeur ajoutée pour les troubles neurologiques.
BioNxt Solutions (OTCQB: BNXTF) hat bedeutende Meilensteine in seinem Reformulierungsprogramm für Cladribin sublingual als Dünnfilmsystem (BNT23001) zur Behandlung von Multipler Sklerose erreicht. Das Unternehmen hat wesentliche Technologietransfers an seinen europäischen CDMO abgeschlossen und den Wirkstoff für die Pilotchargeproduktion bestellt.
Das Unternehmen bereitet sich auf eine Groß-Tier-Bioverfügbarkeitsstudie im Oktober 2025 vor, die bei Schweinen durchgeführt wird, um Dosierung zu validieren und zu optimieren. Diese Studie wird als letzter Schritt der präklinischen Validierung dienen, bevor die Humanstudien fortgesetzt werden. BioNxt plant, seine erstmalige klinische Pilotstudie am Menschen im Q1 2026 durchzuführen, was einen bedeutenden Meilenstein in der Entwicklung der Cladribine-sublingualen Reformulierung darstellt.
Das Programm zielt darauf ab, die Patientenergebnisse durch verbesserte Pharmakokinetik und einfachere Verabreichungsmethoden zu verbessern und sich an den hochpreisigen Pharmamarkt für neurologische Erkrankungen zu richten.
BioNxt Solutions (OTCQB: BNXTF) حققت مراحل مهمة في برنامج إعادة صياغة الدواء الكلادريبين تحت اللسان على هيئة رقيقة فيلمية (BNT23001) لعلاج التصلب المتعدد. أكملت الشركة تحويلات تكنولوجية رئيسية إلى CDMO الأوروبي الخاص بها وطلبت المادة الفعالة لإنتاج دفعة تجريبية.
تستعد الشركة لـ دراسة التوافر الحيوي في حيوانات كبيرة في أكتوبر 2025، باستخدام الخنازير للتحقق من الجرعة وتحسينها. ستشكل هذه الدراسة خطوة التحقق النهائية قبل الانتقال إلى التجارب البشرية. تخطط BioNxt لإجراء دراسة سريرية تجريبية أولى على البشر في الربع الأول من 2026، وهو علامة بارزة في تطوير إعادة صياغة الكلادريبين تحت اللسان.
يهدف البرنامج إلى تحسين نتائج المرضى من خلال تحسين الحركية الدوائية وطرق الإدارة الأكثر بساطة، مستهدفاً السوق الدوائي عالي القيمة للأمراض العصبية.
BioNxt Solutions (OTCQB: BNXTF) 在其用于治疗多发性硬化的克拉地比宁舌下薄膜给药再开发计划(BNT23001)中取得了重要里程碑。公司已完成关键技术转让给其欧洲CDMO，并为试点批量生产订购了活性药物成分。
公司正在为<2025年10月的大动物药代研究做准备，计划使用猪来验证并优化剂量。这项研究将作为进入人体试验前的最后一个非临床验证步骤。BioNxt计划在<2026年第一季度进行首次人体临床试点研究，标志着其克拉地宾舌下再开发的一个重要里程碑。
该计划旨在通过改进药代动力学和更简便的给药方式来改善患者结局，目标是神经系统疾病的高价值制药市场。
- None.
- Product still in early development phase with no revenue generation
- Clinical trials have not yet begun
- Success in animal studies does not guarantee human trial outcomes
VANCOUVER,BC / ACCESS Newswire / September 29, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience company specializing in innovative drug delivery technologies, is pleased to provide an update on its proprietary Cladribine sublingual thin-film drug reformulation program (BNT23001), a next-generation delivery platform designed to improve bioavailability, patient adherence, and therapeutic outcomes in the treatment of neurological disorders, primarily multiple sclerosis (MS).
Cladribine Sublingual Thin-Film Program: Manufacturing and Development Milestones
BioNxt has successfully completed key technology transfers to its European contract development and manufacturing organization ("CDMO"), including both the process transfer and the analytical method transfer. These achievements represent critical steps toward ensuring reproducibility, scalability, and regulatory compliance in the production of the Company's pharmaceutical-grade sublingual thin-film dosage forms.
In parallel, BioNxt confirms that the active pharmaceutical ingredient (API) for Cladribine has been ordered and is currently in transit to the CDMO for use in the manufacturing of a pilot batch. This batch will be used to produce clinical-grade thin film products, advancing the program toward its next preclinical and clinical phases.
The Company is now preparing for the optimization and validation of analytical methods, together with the final refinement of product and process parameters at its CDMO partner. These activities will enable the production of sublingual thin-film samples for a large-animal (pig) bioavailability study, scheduled to begin in October 2025. Pigs are widely recognized as a translationally relevant model for human gastrointestinal absorption, and this study is specifically designed to confirm and strengthen the highly promising bioavailability results demonstrated in earlier animal studies. A successful outcome will provide robust, clinically translatable evidence of the formulation's performance, establishing the final preclinical validation step and dosage optimization prior to human evaluation.
Building on this foundation, BioNxt plans to manufacture a pilot batch for a first-in-human clinical pilot study, targeted for Q1 2026. This milestone trial would represent a major inflection point in the clinical development of BioNxt's Cladribine sublingual reformulation.
Clinical and Market Impact
BioNxt's Cladribine sublingual thin-film program, BNT23001, represents a novel approach to oral drug delivery in neurological disease, with the potential to improve patient outcomes through enhanced pharmacokinetics and ease of administration. The program also complements BioNxt's growing portfolio of proprietary sublingual thin-film technologies targeting high-value pharmaceutical markets.
"With both our development program and global patent strategy advancing on schedule, BioNxt is steadily building the foundation for clinical translation and commercial success," said Hugh Rogers, CEO of BioNxt. "Cladribine represents a powerful therapeutic option with untapped potential, and our sublingual thin-film reformulation may unlock significant advantages in terms of bioavailability, patient adherence, and market accessibility. The progress we are reporting today reinforces our conviction in the program's importance as a core pillar of BioNxt's commercialization pipeline."
Next Steps
Completion of analytical optimization and validation at the European CDMO;
Final process and product optimization, followed by clinical sample production;
Initiation of a large-animal bioavailability study in October 2025, expected to be the final preclinical study before human trials;
Preparation for the manufacture of clinical samples for the first-in-human clinical study in Q1 2026; and
Ongoing patent nationalizations and accelerated US patent review under Track One.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 604.250.6162
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding "Forward-Looking" Information
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company's plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company's Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt's sublingual thin-film drug delivery platform across additional therapeutic areas.
Forward-looking information is based on management's current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company's control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
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