BioNxt Launches 15-day Sublingual Cladribine Dosing Optimization Study in Preparation for Human Bioequivalence Study
BioNxt (OTCQB:BNXTF) launched a 15-day large-mass animal crossover bioequivalence study for BNT23001, its sublingual cladribine thin-film, to refine dosing prior to a human comparative bioequivalence study planned for early 2026.
The animal study will begin in the next 2–3 weeks, run for 15 days, is expected to complete in November 2025, and results are expected in December 2025. A prior small-mass (40 kg) animal study reportedly confirmed dosage bioequivalence and guided dosing direction.
BNT23001 aims for improved bioavailability, faster onset, and easier dosing for patients with dysphagia. The company is pursuing patent nationalization in key markets; the European Patent Office and Eurasian Patent Office issued notices of intentions to grant, and a Track One priority filing is active in the United States.
BioNxt (OTCQB:BNXTF) ha avviato uno studio crossover di equivalenza biofarmaceutica su animali a grande massa della durata di 15 giorni per BNT23001, la sua formulazione sublinguale a base di cladribina in film sottolinguale, al fine di affinare il dosaggio prima di uno studio comparativo sullequivalenza biofarmaceutica nell’uomo previsto per l’inizio del 2026.
Lo studio sugli animali inizierà nelle prossime 2–3 settimane, durerà 15 giorni, dovrebbe essere completato entro novembre 2025 e i risultati sono previsti per dicembre 2025. Uno studio animale precedente su piccola massa (40 kg) avrebbe confermato la bioequivalenza della posologia e guidato l’assetto del dosaggio.
BNT23001 punta a una migliore biodisponibilità, a un onset più rapido e a un dosaggio più semplice per i pazienti con disfagia. L’azienda sta perseguendo la nazionalizzazione dei brevetti nei mercati chiave; l’Ufficio europeo dei brevetti e l’Ufficio brevetti eurasiatico hanno emesso avvisi di intenzione di concessione, e una domanda con priorità Track One è attiva negli Stati Uniti.
BioNxt (OTCQB:BNXTF) lanzó un estudio de bioequivalencia en crossover en animales de gran masa de 15 días para BNT23001, su película delgada sublingual de cladribina, para refinar la dosificación antes de un estudio de bioequivalencia comparativa en humanos previsto para principios de 2026.
El estudio en animales comenzará en las próximas 2–3 semanas, tendrá una duración de 15 días, se espera que se complete en noviembre de 2025, y se esperan resultados en diciembre de 2025. Un estudio anterior en animales de masa pequeña (40 kg) habría confirmado la bioequivalencia de la dosis y guiado la dirección de la dosificación.
El BNT23001 apunta a una mayor biodisponibilidad, un inicio más rápido y una dosificación más fácil para pacientes con disfagia. La empresa está buscando la nacionalización de patentes en mercados clave; la Oficina Europea de Patentes y la Oficina de Patentes Eurasiática emitieron avisos de intención de conceder, y una presentación de prioridad Track One está activa en los Estados Unidos.
BioNxt (OTCQB:BNXTF)는 BNT23001, 혀밑 닿는 클라드리빈 얇은 필름에 대한 대량 동물 교차 생물학적 등가성 연구를 15일간 시작했습니다. 이는 2026년 초에 계획된 인간 비교 생물학적 등가성 연구를 위한 용량 조정을 위한 것입니다.
동물 연구는 향후 2–3주 내에 시작되고, 15일간 진행되며, 2025년 11월에 완료될 것으로 예상되며, 결과는 2025년 12월에 발표될 예정입니다. 소대(40 kg) 동물 연구는 이미 약물 용량의 생물학적 등가성을 확인하고 용량 방향을 안내한 것으로 전해집니다.
BNT23001은 생체이용률 증가, 더 빠른 시작 및 삼킴장애 환자용 더 쉬운 용량 조절을 목표로 합니다. 이 회사는 주요 시장에서 특허 국유화를 추진 중이며, 유럽 특허청과 유라시아 특허청이 부여 의도 통지를 발행했고 미국에서 Track One 우선 특허 출원이 활성화되어 있습니다.
BioNxt (OTCQB:BNXTF) a lancé une étude d’équivalence biologique traversante chez l’animal de 15 jours à grande masse pour le BNT23001, son film fin sous-langual à la cladribine, afin d’affiner le dosage avant une étude d’équivalence biologique comparative sur l’homme prévue pour début 2026.
L’étude animale débutera dans les 2–3 semaines à venir, durera 15 jours, devrait être achevée en novembre 2025, et les résultats sont attendus en décembre 2025. Une étude animale précédente à masse réduite (40 kg) aurait confirmé l’équivalence de dosage et guidé l’orientation du dosage.
Le BNT23001 vise une meilleure biodisponibilité, un début plus rapide et un dosage plus facile pour les patients souffrant de dysphagie. L’entreprise poursuit la nationalisation des brevets sur les marchés clés ; l’Office européen des brevets et l’Office européen des brevets eurasiatique ont émis des Avis d’intention d’octroi, et une demande prioritaire Track One est active aux États-Unis.
BioNxt (OTCQB:BNXTF) hat eine 15-tägige Crossover-Studie zur biologischen Äquivalenz bei Tieren großer Masse für BNT23001 gestartet, seine sublinguale Cladribin-Dünnfilm-Formulierung, um die Dosierung vor einer menschlichen Vergleichs-Biologische-Äquivalenz-Studie, die für Anfang 2026 geplant ist, zu verfeinern.
Die Tierversuchs-Studie wird in den nächsten 2–3 Wochen beginnen, 15 Tage dauern, voraussichtlich im November 2025 abgeschlossen sein und die Ergebnisse werden voraussichtlich im Dezember 2025 vorliegen. Eine frühere Tierversuchs-Studie mit kleiner Masse (40 kg) soll die Dosierungsbioäquivalenz bestätigt und die Dosierungsrichtung geführt haben.
Ziel von BNT23001 ist eine verbesserte Bioverfügbarkeit, ein schnellerer Wirkungseintritt und eine einfachere Dosierung für Patienten mit Dysphagie. Das Unternehmen verfolgt eine Patent-Nationalisierung in Schlüsselmärkte; das Europäische Patentamt und das Eurasian Patent Office haben Benachrichtigungen über Absicht zur Grantierung ausgestellt, und eine Track-One-Prioritätsanmeldung ist in den USA aktiv.
BioNxt (OTCQB:BNXTF) أطلقت دراسة تقاطع بيولوجي للمقارنة الحيوية لدى الحيوانات ذات الكتلة الكبيرة لمدة 15 يوماً من أجل BNT23001، وهي طبقة-film شفوية أسفل اللسان تحتوي على كلادريبين، من أجل تحسين الجرعة قبل دراسة مقارنة بيولوجية بشرية مخطط لها في أوائل 2026.
ستبدأ الدراسة الحيوانية في خلال الـ2–3 أسابيع المقبلة، وتستمر 15 يوماً، ومن المتوقع أن تكتمل في نوفمبر 2025، وتُتوقع النتائج في ديسمبر 2025. وذكرت دراسة حيوانية سابقة ذات كتلة صغيرة (40 كغ) أنها أكدت التماثل البيولوجي للجرعة ووجهت اتجاه الجرعة.
يهدف BNT23001 إلى تحسين التوافر الحيوي، وبدء أسرع، وتسهيل الجرعة للمرضى المصابين باضطراب البلع. تسعى الشركة إلى توطين براءات الاختراع في الأسواق الرئيسية؛ وقد أصدرت مكتب براءات الاختراع الأوروبي ومكتب براءات الاختراع الأوروآسيا إشعارات بنوايا منح، وهناك تسجيل أولوية Track One نشط في الولايات المتحدة.
BioNxt (OTCQB:BNXTF) 启动了一项为期 15 天的大质量动物交叉生物等效性研究，针对 BNT23001——其舌下片剂薄膜中的氯达比苯啶药物，以在计划于 2026 年初进行的人体比较生物等效性研究之前优化给药。
动物研究将在接下来的 2–3 周内开始，持续 15 天，预计在 2025 年 11 月完成，结果预计在 2025 年 12 月公布。此前的一项小质量（40 kg）动物研究据称已证实药物剂量的生物等效性并指导了给药方向。
BNT23001 旨在提高生物利用度、加快起效时间以及为吞咽困难患者提供更易用的给药方式。公司正在关键市场推进专利国家化；欧洲专利局和欧亚专利局发出了授予意向通知，美国也有 Track One 优先权申请在案。
- 15-day large-mass animal study initiated to refine human dosing
- Human comparative bioequivalence study planned for early 2026
- Preclinical studies reported high absorption and no toxicity
- EPO and Eurasian offices issued notices of intentions to grant patents
- No human comparative bioequivalence results yet; study planned for early 2026
- Patent nationalization ongoing; favorable communications are not final grants
VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies, is pleased to announce the launch of an important large-mass animal bioequivalence study for its lead product, BNT23001, a proprietary sublingual Cladribine formulation for the treatment of multiple sclerosis ("MS"). This is the final animal study to generate dosing parameters for the Company's human comparative bioequivalence study planned for early 2026.
"The Company has already confirmed dosage bioequivalence in small-mass (<20kgs) animals; however, a large-mass (>40kgs) animal study will provide valuable insight into the appropriate sublingual drug load for humans," Hugh Rogers, CEO of BioNxt. "This large-mass animal study is expected to increase the formula precision in our human study and is designed to generate comparative drug absorption results between the Company's sublingual formulation versus the name brand tablet formulation. Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative human bioequivalence study."
The large-mass animal crossover bioequivalence study will commence in the next two to three weeks and will be carried out over the following 15 days. The study is expected to be completed in November with results available in December.
BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound used for the treatment of MS. Delivered sublingually, the formulation is designed for improved bioavailability, faster onset of action, and enhanced patient compliance, particularly in populations affected by dysphagia or seeking non-invasive alternatives to traditional tablets or injections. Preclinical studies, as previously reported, have demonstrated high absorption rates and bioequivalence to existing oral therapies as well as zero indications of toxicity.
The patent nationalization process is underway in key global markets, including the European Union, Canada, Australia, Eurasia, New Zealand, and Japan, as well a Track One priority filing in the United States. Both the European Patent Office and the Eurasian Patent Office have issued favorable communications, including notice of intentions to grant. Novelty, inventive step, and industrial applicability were fully accepted.
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
FAQ
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