BioNxt Delivers Positive Results in Patented Cladribine Sublingual Thin-Film Program and Completes Successful Formulation
BioNxt Solutions (OTC:BNXTF) has successfully developed a prototype sublingual thin-film formulation for BNT23001, using cladribine as the active pharmaceutical ingredient for multiple sclerosis treatment. The prototype, developed with European partner Gen-Plus GmbH, demonstrated promising characteristics in drug loading, film uniformity, and disintegration time.
The company aims to initiate human bioequivalence studies in H2 2025. BNT23001 is designed as an alternative to conventional oral cladribine tablets like Mavenclad®, specifically targeting MS patients with dysphagia. The company is advancing its IP strategy with patent nationalization processes in Europe, the United States, and Canada.
BioNxt Solutions (OTC:BNXTF) ha sviluppato con successo un prototipo di formulazione sublinguale a film sottile per BNT23001, utilizzando cladribina come principio attivo per il trattamento della sclerosi multipla. Il prototipo, realizzato in collaborazione con il partner europeo Gen-Plus GmbH, ha mostrato caratteristiche promettenti in termini di carico del farmaco, uniformità del film e tempo di disintegrazione.
L'azienda punta ad avviare studi di bioequivalenza umana nella seconda metà del 2025. BNT23001 è stato progettato come alternativa alle tradizionali compresse orali di cladribina come Mavenclad®, rivolgendosi in particolare ai pazienti con sclerosi multipla affetti da disfagia. La società sta inoltre potenziando la sua strategia di proprietà intellettuale con processi di nazionalizzazione dei brevetti in Europa, Stati Uniti e Canada.
BioNxt Solutions (OTC:BNXTF) ha desarrollado con éxito un prototipo de formulación sublingual en película delgada para BNT23001, utilizando cladribina como ingrediente farmacéutico activo para el tratamiento de la esclerosis múltiple. El prototipo, desarrollado con el socio europeo Gen-Plus GmbH, mostró características prometedoras en la carga del fármaco, uniformidad de la película y tiempo de desintegración.
La compañía tiene como objetivo iniciar estudios de bioequivalencia en humanos en la segunda mitad de 2025. BNT23001 está diseñado como una alternativa a las tabletas orales convencionales de cladribina como Mavenclad®, dirigido específicamente a pacientes con esclerosis múltiple que padecen disfagia. La empresa está avanzando en su estrategia de propiedad intelectual con procesos de nacionalización de patentes en Europa, Estados Unidos y Canadá.
BioNxt Solutions (OTC:BNXTF)는 다발성 경화증 치료를 위한 활성 약물 성분인 클라드리빈을 사용하여 BNT23001의 설하용 박막 제형 프로토타입을 성공적으로 개발했습니다. 유럽 파트너인 Gen-Plus GmbH와 함께 개발된 이 프로토타입은 약물 적재, 필름 균일성 및 해리 시간에서 유망한 특성을 보였습니다.
회사는 2025년 하반기 인체 생물학적 동등성 시험을 시작할 계획입니다. BNT23001은 Mavenclad®와 같은 기존 경구용 클라드리빈 정제의 대안으로 설계되었으며, 특히 연하곤란이 있는 다발성 경화증 환자를 대상으로 합니다. 회사는 유럽, 미국 및 캐나다에서 특허 국가지정 절차를 통해 지식재산권 전략을 강화하고 있습니다.
BioNxt Solutions (OTC:BNXTF) a développé avec succès un prototype de formulation sublinguale en film mince pour BNT23001, utilisant la cladribine comme principe actif pour le traitement de la sclérose en plaques. Le prototype, développé avec le partenaire européen Gen-Plus GmbH, a montré des caractéristiques prometteuses en termes de charge médicamenteuse, d’uniformité du film et de temps de désintégration.
L’entreprise vise à lancer des études de bioéquivalence humaine au second semestre 2025. BNT23001 est conçu comme une alternative aux comprimés oraux conventionnels de cladribine tels que Mavenclad®, ciblant spécifiquement les patients SEP souffrant de dysphagie. La société fait progresser sa stratégie de propriété intellectuelle avec des procédures de nationalisation de brevets en Europe, aux États-Unis et au Canada.
BioNxt Solutions (OTC:BNXTF) hat erfolgreich einen Prototyp einer sublingualen Dünnfilmformulierung für BNT23001 entwickelt, wobei Cladribin als Wirkstoff für die Behandlung der Multiplen Sklerose verwendet wird. Der Prototyp, der in Zusammenarbeit mit dem europäischen Partner Gen-Plus GmbH entwickelt wurde, zeigte vielversprechende Eigenschaften hinsichtlich Wirkstoffbeladung, Filmuniformität und Zerfallzeit.
Das Unternehmen plant, im zweiten Halbjahr 2025 Human-Bioäquivalenzstudien zu starten. BNT23001 ist als Alternative zu herkömmlichen oralen Cladribin-Tabletten wie Mavenclad® konzipiert und richtet sich speziell an MS-Patienten mit Schluckbeschwerden. Das Unternehmen treibt seine IP-Strategie mit Patentnationalisierungsverfahren in Europa, den Vereinigten Staaten und Kanada voran.
- None.
- Product still in early development phase with no clinical data yet
- Future clinical trials and regulatory approvals still required
- Competition from established treatments like Mavenclad®
VANCOUVER, BC / ACCESS Newswire / July 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce the successful formulation of a sublingual thin-film prototype for its lead clinical stage candidate, BNT23001, using the active pharmaceutical ingredient (API) cladribine. This proprietary thin-film formulation is being developed for the treatment of multiple sclerosis (MS).
The cladribine API was used by BioNxt's European drug development partner, Gen-Plus GmbH & Co. KG, based in Munich, Germany, to develop and produce prototype oral dissolvable films (ODFs). These initial formulations demonstrated promising characteristics in terms of drug loading, film uniformity, and disintegration time, confirming the suitability of cladribine for thin-film drug delivery.
This formulation milestone strengthens the foundation for clinical batch manufacturing and further optimization, which are ongoing as part of BioNxt's strategy to initiate a human bioequivalence study in the second half of 2025.
Strategic Milestone in BioNxt's Cladribine Development Path
BNT23001 is designed to offer a patient-centric alternative to conventional oral cladribine tablets, such as Mavenclad®, by delivering the drug through a rapidly dissolving sublingual film. This approach aims to improve treatment adherence, particularly for MS patients who experience dysphagia, a common symptom that affects the ability to swallow.
BioNxt's proprietary thin-film platform enables precise and rapid drug absorption via the oral mucosa, offering potential advantages in bioavailability, convenience, and patient experience over traditional oral or injectable formats.
In parallel with formulation progress, BioNxt continues to advance its intellectual property strategy. The company believes that continued validation of the product and further experimental data will support additional IP filings, with patent protection representing a key upcoming milestone for BNT23001. BioNxt has already initiated patent nationalization processes in Europe, the United States, and Canada.
"The successful formulation of the first cladribine-containing thin-film prototype marks a major step forward in the clinical development of BNT23001," said Hugh Rogers, CEO of BioNxt Solutions. "It also underscores the strength of our drug delivery platform as we move toward human trials and eventual commercial readiness."
BioNxt expects to continue formulation optimization and begin in vitro performance testing, with preclinical evaluation to follow as the Company advances toward regulatory readiness and potential out-licensing opportunities.
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 press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.
Mavenclad® is a registered trademark of Merck KGaA, Darmstadt, Germany. It is not affiliated with or endorsed by BioNxt Solutions Inc.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
FAQ
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