BioNxt
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BioNxt Advances ODF for Multiple Sclerosis into Human Trials with Over 40% Bioavailability Boost and Expands to Myasthenia Gravis
BioNxt Solutions Inc. is advancing its cladribine oral thin film (ODF) program, showing over 40% improved bioavailability in preclinical studies. This progress supports initiating clinical trials for Multiple Sclerosis (MS) and expanding to Myasthenia Gravis (MG), leveraging a capital-efficient strategy with an established API. The ODF platform aims to enhance patient adherence and simplify administration for chronic neurological and autoimmune conditions, targeting substantial and growing markets.
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BioNxt Initiates 15-Day Sublingual Cladribine Optimization Study for Bioequivalence Trial
BioNxt (BNXTF) has initiated a large-mass animal study for BNT23001, a sublingual cladribine film for multiple sclerosis, to optimize dosing before human trials planned for early 2026. The study, expected to complete in November 2025 with results in December 2025, aims to improve bioavailability and simplify dosing. Patent nationalization is ongoing, with positive notices from European and Eurasian Patent Offices, and a priority filing in the US. BNT23001 targets improved outcomes for dysphagia patients, offering a non-tablet option.
