BioNxt Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine Delivery for the Treatment Multiple Sclerosis (MS)

Executive Summary

• BioNxt Solutions reported final results of a pre‑clinical pig study showing its sublingual oral dissolvable film (ODF) formulation of cladribine delivers ~40 % higher systemic exposure than a conventional oral tablet.
• Mean AUC₀‑₄₈h was 39.46 ng·h/mL for the ODF versus 28.11 ng·h/mL for the tablet, indicating substantially improved drug delivery.
• The company will advance the sublingual ODF into human pharmacokinetic and bioequivalence studies and is exploring broader platform applications beyond multiple sclerosis.

Key Details

• Study design: Single‑dose comparative evaluation in adult miniature pigs (40–50 kg), a large‑mass non‑rodent model with high translational relevance to humans.
• Pharmacokinetic outcome: AUC₀‑₄₈h for sublingual ODF = 39.46 ng·h/mL; AUC₀‑₄₈h for conventional tablet = 28.11 ng·h/mL, representing ~40 % higher exposure.
• Exposure advantage supports de‑risking of the clinical development pathway and provides a quantitative basis for dose optimization, potentially reducing systemic drug burden and side effects.
• Administration method: Animals were physically restrained during dosing to prevent swallowing, ensuring pure transmucosal absorption for the ODF.
• Next steps: Proceed to human PK and bioequivalence studies; continue GMP manufacturing and regulatory preparation.
• Platform outlook: BioNxt views its sublingual ODF technology as a scalable delivery platform applicable to other neuro‑immunological diseases (e.g., Myasthenia Gravis) and late‑stage drug candidates, aiming for improved adherence, tolerability, and patient convenience.

Notable Quotes

• “These final preclinical pig study results validate the efficiency of our proprietary sublingual delivery approach and provide quantitative confirmation that our ODF delivers cladribine more efficiently than conventional oral tablets,” – Hugh Rogers, CEO, BioNxt Solutions Inc.