Bionxt discusses cladribine ODF study

Executive Summary

• Bionxt Solutions Inc. completed a comparative pharmacokinetics (PK) study in large-mass animals (pigs) evaluating its proprietary sublingual orally dissolving film (ODF) formulation of cladribine against the reference name-brand tablet.
• The study results were successful, demonstrating superior bioavailability for the sublingual ODF formulation compared to the conventional oral tablet.
• The company is currently conducting a full internal screening and assessment of the final data set to calculate key pharmacokinetic parameters, with further details to be released upon completion of this analysis.

Key Details

• Study Type: Comparative pharmacokinetics (PK) large-mass animal study in pigs.
• Objective: To measure the efficiency of cladribine absorption into the bloodstream and compare Bionxt’s swallow-free, sublingual ODF formulation with the reference tablet formulation.
• Subjects: Adult pigs weighing approximately 40 to 50 kilograms, selected for their high physiological, anatomical, and metabolic similarities to humans regarding drug absorption and systemic exposure.
• Dosage: Both formulations were administered at a single dose equivalent to 5 mg of cladribine per animal.
• Administration Methods:
  • Reference tablet: Administered by oral dosing via gavage.
  • Bionxt ODF: Placed directly into the oral cavity to support sublingual absorption.
• Data Collection: Blood samples were collected before dosing and at several time points over 24 hours post-administration to measure peak concentration, overall exposure, and duration of presence in the body.
• Study Timeline: Initiated in November 2025 and completed in December 2025.
• Strategic Implications:
  • Enhanced bioavailability allows for therapeutic exposure with lower overall systemic drug exposure, potentially reducing dose-related side effects and improving patient tolerability.
  • The swallow-free format aims to improve patient experience, particularly for those with swallowing difficulties.
  • Data is critical for optimizing dosing parameters in upcoming human bioequivalence studies.
• Market Context: Cladribine (Mavenclad) is a high-efficacy MS therapy with annual global sales exceeding $1 billion. The global MS drug market is forecasted to exceed $41 billion by 2033.
• Intellectual Property: Patent protection for the cladribine ODF program has been confirmed, with final national-level patent grants expected shortly.
• Next Steps: Bionxt is finalizing internal calculations and interpretation of the data and will provide additional disclosures once the comprehensive internal analysis is complete.

Notable Quotes

• "We are extremely encouraged by the successful outcome of this study... The results reinforce our belief that sublingual ODF delivery can materially improve the efficiency of cladribine administration and may ultimately support better patient tolerability and adoption." — Hugh Rogers, Chief Executive Officer