Bionxt talks cladribine preclinical pig study results

Executive Summary

• Bionxt Solutions reports final pre‑clinical pig study showing its sublingual oral dissolvable film (ODF) formulation of cladribine delivers ~40 % higher systemic exposure (AUC) 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 a substantial pharmacokinetic advantage.
• The company plans to advance the ODF into human PK and bioequivalence studies, positioning it as a potential platform for multiple neuro‑immunological indications beyond MS.

Key Details

• Study Design: Single‑dose comparative evaluation in adult miniature pigs (40–50 kg); animals restrained to prevent swallowing during sublingual dosing.
• Pharmacokinetic Outcome: AUC₀‑₄₈h for ODF = 39.46 ng·h/mL; AUC₀‑₄₈h for tablet = 28.11 ng·h/mL → ~40 % higher exposure with ODF.
• Interpretation: Higher AUC reflects greater amount of cladribine reaching systemic circulation and persisting longer, suggesting improved delivery efficiency that could enable dose optimization and better tolerability.
• Regulatory Path Forward: Bionxt intends to initiate human pharmacokinetic and bioequivalence studies; continues GMP manufacturing and regulatory preparation for the ODF platform.
• Platform Potential: While MS is the initial focus, Bionxt sees applicability of the sublingual ODF technology to other neuro‑immunological diseases such as myasthenia gravis, leveraging its swallow‑free, needle‑free delivery advantages.
• Strategic Rationale: Reformulating approved active ingredients via the ODF platform may streamline development (focus on PK/bioequivalence rather than new molecular discovery) and expand market opportunities across chronic neurological conditions.

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

All forward‑looking statements are subject to risks and uncertainties; actual results may differ.