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Vancouver biotech BioNxt hits MS drug milestones, files clinical trial application in EU
BioNxt announced its sublingual cladribine film BNT23001 completed GMP manufacturing of about 1,500 films and a clinical trial application was filed via the EU's CTIS on Oct. 16.
Why it matters
Vancouver bioscience company BioNxt Solutions Inc. announced on Monday (Oct. 19) two development milestones for BNT23001, its drug candidate for relapsing forms of multiple sclerosis (MS): it completed Good Manufacturing Practice (GMP) production and formally filed a clinical trial application in the European Union, bringing its planned first human study a step closer.
Full report
BNT23001 is BioNxt's proprietary sublingual cladribine oral dissolvable film (ODF). The company said it completed GMP manufacturing of approximately 1,500 investigational films and submitted its Clinical Trial Application through the EU's Clinical Trials Information System (CTIS) on Oct. 16, 2026, building on the completion of its Investigational Medicinal Product Dossier announced in August 2026.
What comes next
Subject to regulatory authorization and completion of remaining pharmaceutical quality requirements, the company intends to run a comparative human pharmacokinetic and bioequivalence study against Mavenclad, the approved oral cladribine tablet. BioNxt is listed in Canada (CSE:BNXT), on the U.S. OTCQB (BNXTF) and in Frankfurt (FSE:BXT), specializing in advanced drug delivery systems.
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