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BioNxt Reports Sublingual Cladribine Multiple Sclerosis Drug Milestones Including Large-Animal Study for Validation and Dosing Optimization
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 ...
About this update from Bionxt Solutions Inc
[{"type":"text","content":"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).","length":551,"tagName":"p"},{"type":"text","content":"Cladribine Sublingual Thin-Film Program: Manufacturing and Development Milestones","length":81,"tagName":"p"},{"type":"text","content":"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.","length":429,"tagName":"p"},{"type":"text","content":"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.","length":336,"tagName":"p"},{"type":"text","content":"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 ...