BioNxt's Sublingual Cladribine Program for MS Ready for Next Phase
BioNxt Solutions (OTC:BNXTF) has reached a significant milestone in its multiple sclerosis (MS) drug development program with the receipt of the active pharmaceutical ingredient (API) for BNT23001, their proprietary sublingual thin-film formulation of cladribine.
The company will now proceed with clinical batch manufacturing through their European partner, Gen-Plus GmbH & Co KG, in preparation for a human bioequivalence study planned for H2 2025. BNT23001 is designed as an alternative to traditional oral cladribine tablets like Mavenclad®, offering a rapidly dissolving sublingual film particularly beneficial for MS patients with swallowing difficulties.
Preclinical studies have shown promising results with high absorption rates and bioequivalence to existing oral therapies, without toxic effects. The company is also advancing patent applications in key markets including Europe, the US, and Canada.
BioNxt Solutions (OTC:BNXTF) ha raggiunto un traguardo importante nel suo programma di sviluppo di farmaci per la sclerosi multipla (SM) con la ricezione del principio attivo farmaceutico (API) per BNT23001, la loro formulazione proprietaria a film sottolinguale di cladribina.
L'azienda procederà ora alla produzione del lotto clinico tramite il partner europeo Gen-Plus GmbH & Co KG, in preparazione a uno studio di bioequivalenza umana previsto per la seconda metà del 2025. BNT23001 è concepito come alternativa alle tradizionali compresse orali di cladribina come Mavenclad®, offrendo un film sottolinguale a rapido scioglimento, particolarmente vantaggioso per i pazienti con SM che hanno difficoltà a deglutire.
Gli studi preclinici hanno mostrato risultati promettenti con elevati tassi di assorbimento e bioequivalenza rispetto alle terapie orali esistenti, senza effetti tossici. L'azienda sta inoltre avanzando con le domande di brevetto nei mercati chiave, tra cui Europa, Stati Uniti e Canada.
BioNxt Solutions (OTC:BNXTF) ha alcanzado un hito significativo en su programa de desarrollo de medicamentos para la esclerosis múltiple (EM) con la recepción del ingrediente farmacéutico activo (API) para BNT23001, su formulación propietaria de película sublingual de cladribina.
La compañía procederá ahora con la fabricación del lote clínico a través de su socio europeo, Gen-Plus GmbH & Co KG, en preparación para un estudio de bioequivalencia humana planeado para la segunda mitad de 2025. BNT23001 está diseñado como una alternativa a las tabletas orales tradicionales de cladribina como Mavenclad®, ofreciendo una película sublingual de rápida disolución especialmente beneficiosa para pacientes con EM que tienen dificultades para tragar.
Los estudios preclínicos han mostrado resultados prometedores con altas tasas de absorción y bioequivalencia a las terapias orales existentes, sin efectos tóxicos. La compañía también está avanzando en las solicitudes de patente en mercados clave, incluyendo Europa, EE.UU. y Canadá.
BioNxt Solutions (OTC:BNXTF)는 다발성 경화증(MS) 약물 개발 프로그램에서 중요한 이정표를 달성했으며, 클라드리빈의 독자적인 설하 박막 제형인 BNT23001의 활성 약물 성분(API)을 확보했습니다.
회사는 유럽 파트너인 Gen-Plus GmbH & Co KG를 통해 임상 배치 제조를 진행할 예정이며, 2025년 하반기에 계획된 인간 생물학적 동등성 연구를 준비하고 있습니다. BNT23001은 Mavenclad®와 같은 전통적인 경구용 클라드리빈 정제의 대안으로 설계되었으며, 삼키기 어려운 MS 환자에게 특히 유용한 빠르게 용해되는 설하 박막을 제공합니다.
전임상 연구에서 높은 흡수율과 기존 경구 치료제와의 생물학적 동등성이 입증되었으며, 독성 효과는 없었습니다. 회사는 또한 유럽, 미국, 캐나다 등 주요 시장에서 특허 출원을 진행 중입니다.
BioNxt Solutions (OTC:BNXTF) a atteint une étape importante dans son programme de développement de médicaments pour la sclérose en plaques (SEP) avec la réception de l'ingrédient pharmaceutique actif (API) pour BNT23001, leur formulation propriétaire de film sublingual de cladribine.
L'entreprise va maintenant procéder à la fabrication du lot clinique via son partenaire européen, Gen-Plus GmbH & Co KG, en préparation d'une étude de bioéquivalence humaine prévue pour le second semestre 2025. BNT23001 est conçu comme une alternative aux comprimés oraux traditionnels de cladribine tels que Mavenclad®, offrant un film sublingual à dissolution rapide particulièrement bénéfique pour les patients SEP ayant des difficultés à avaler.
Les études précliniques ont montré des résultats prometteurs avec des taux d'absorption élevés et une bioéquivalence aux thérapies orales existantes, sans effets toxiques. L'entreprise fait également progresser ses demandes de brevet sur des marchés clés, notamment en Europe, aux États-Unis et au Canada.
BioNxt Solutions (OTC:BNXTF) hat einen bedeutenden Meilenstein in seinem Entwicklungsprogramm für Multiple-Sklerose-Medikamente erreicht, indem der Wirkstoff (API) für BNT23001, ihre proprietäre sublinguale Dünnfilmformulierung von Cladribin, erhalten wurde.
Das Unternehmen wird nun mit der Herstellung klinischer Chargen über seinen europäischen Partner Gen-Plus GmbH & Co KG fortfahren, um sich auf eine für die zweite Hälfte 2025 geplante humanbiologische Äquivalenzstudie vorzubereiten. BNT23001 ist als Alternative zu herkömmlichen oralen Cladribin-Tabletten wie Mavenclad® konzipiert und bietet einen schnell löslichen sublingualen Film, der besonders vorteilhaft für MS-Patienten mit Schluckbeschwerden ist.
Präklinische Studien zeigten vielversprechende Ergebnisse mit hohen Absorptionsraten und Bioäquivalenz zu bestehenden oralen Therapien, ohne toxische Effekte. Das Unternehmen treibt außerdem Patentanmeldungen in wichtigen Märkten wie Europa, den USA und Kanada voran.
- Successful completion of preclinical studies showing high absorption rates and bioequivalence
- Patent applications in progress for key markets (Europe, US, Canada)
- Ready to commence clinical batch manufacturing for human trials
- Product addresses specific MS patient needs, particularly those with dysphagia
- Human trials yet to begin
- Patent grants still pending
- Potential competition from established treatments like Mavenclad
VANCOUVER, BC / ACCESS Newswire / July 7, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC:XPHYF)(FSE:4XT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce the receipt of the active pharmaceutical ingredient (API) for its lead product candidate, BNT23001. This proprietary sublingual thin-film formulation of cladribine is being developed for the treatment of multiple sclerosis (MS).
The delivery of the cladribine API enables the commencement of clinical batch manufacturing in collaboration with BioNxt's European contract research and development partner, Gen-Plus GmbH & Co KG, based in Munich, Germany. This milestone supports the company's plan to initiate a human bioequivalence study in the second half of 2025.
BNT23001 is designed to offer a patient-friendly alternative to traditional oral cladribine tablets, such as Mavenclad®, by providing a rapidly dissolving sublingual film. This delivery method aims to enhance patient compliance, particularly for individuals with MS who experience dysphagia, a common symptom affecting the ability to swallow.
Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse toxic effects observed. These findings support the progression to human bioequivalence studies.
BioNxt has also made significant strides in securing intellectual property rights for BNT23001. The company has initiated patent nationalization processes in key jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated by mid-2025.
"The receipt of the cladribine API is a pivotal step forward in our mission to develop innovative, patient-centric therapies for MS," said Hugh Rogers, CEO of BioNxt Solutions. "We are committed to advancing BNT23001 through clinical development and bringing this novel treatment option to patients worldwide."
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next‐generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin‐Film), Transdermal (Skin Patch), and Oral (Enteric‐Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
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: +1 778.598.2698
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 news release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
SOURCE: BioNxt Solutions Inc.
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