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.
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“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.”
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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.