Canada-based bioscience company BioNxt Solutions Inc. (CSE: BNXT, OTCQB:BNXTF, FSE: BXT) announced on Thursday that it has initiated a 15-day dosing optimisation study for its lead product, BNT23001, a proprietary sublingual Cladribine formulation being developed as a new treatment option for multiple sclerosis.

This study represents the final preclinical phase before BioNxt's planned human bioequivalence trials set for early 2026. The research aims to refine dosing precision in large-mass animal models and generate comparative drug absorption data against the existing tablet formulation.

BNT23001, an orally dissolvable thin film designed for sublingual delivery, seeks to improve absorption, bioavailability, and patient comfort compared to traditional oral tablets. Preclinical trials have shown strong absorption rates, bioequivalence, and no toxicity concerns.

In parallel, BioNxt is advancing global patent nationalisation across key regions, with the European Patent Office and Eurasian Patent Office issuing intent-to-grant communications.

With dosing optimisation underway and intellectual property protections expanding, BioNxt says it is positioning itself for human trials that could redefine the delivery of multiple sclerosis treatments.

The study is expected to run into November, with results due in December.