Core Insights - BioNxt Solutions Inc. has initiated a 15-day dosing optimization study for its lead product BNT23001, a sublingual Cladribine formulation aimed at treating multiple sclerosis, marking the final step before human bioequivalence testing set for early 2026 [1][2][10] Company Developments - The upcoming large-mass animal study will refine dosing precision and optimize the formulation, following successful small-animal trials that confirmed bioequivalence [2][3] - The 15-day crossover study is expected to begin within two weeks, with completion anticipated in November and results due in December [4] - BNT23001 is designed to provide faster absorption and improved bioavailability, catering to patients who may struggle with traditional tablet forms [5][6] Intellectual Property Strategy - BioNxt is advancing its patent nationalization strategy across key markets, including Canada, Australia, the EU, Eurasia, New Zealand, and Japan, with a priority filing in the US [7][9] - Favorable communications from the European Patent Office and the Eurasian Patent Office have reinforced the company's intellectual property position ahead of human trials [8][10] Future Outlook - The comparative human bioequivalence study will measure drug absorption between BioNxt's sublingual formulation and the existing tablet version of Cladribine, aiming to validate a more patient-friendly treatment approach [9][10]