Bionxt begins BNT23001 animal bioequivalence study

Executive Summary

• Bionxt Solutions Inc. has launched a 15-day large-mass animal bioequivalence study for its lead product, BNT23001 (sublingual cladribine), to determine dosing parameters for an upcoming human bioequivalence study.
• The study aims to optimize drug load and assess super bioavailability by comparing the sublingual formulation against the name-brand tablet formulation in animals weighing greater than 40 kilograms.
• The company has received favorable communications from the European Patent Office and the Eurasian Patent Office regarding patent applications, with intentions to grant noted.

Key Details

• Study Launch: Initiation of a large-mass animal crossover bioequivalence study for BNT23001.
• Study Timeline:
  • Commencement: Within the next two to three weeks from the release date.
  • Duration: 15 days.
  • Completion: Expected in November.
  • Results Availability: Expected in December.
• Study Objectives:
  • Generate comparative drug absorption results between the sublingual formulation and the name-brand tablet formulation.
  • Optimize drug load per dose.
  • Assess potential super bioavailability.
  • Provide data to guide final clinical planning for the human-comparative bioequivalence study planned for early 2026.
• Previous Data: Bioequivalence has already been confirmed in small-mass animals (less than 20 kilograms).
• Product Profile (BNT23001):
  • Orally dissolvable thin-film formulation of cladribine.
  • Designed for improved bioavailability, faster onset of action, and enhanced patient compliance (particularly for dysphagia patients).
  • Preclinical studies showed high absorption rates, bioequivalence to existing oral therapies, and zero indications of toxicity.
• Patent Status:
  • Nationalization process underway in key global markets: European Union, Canada, Australia, Eurasia, New Zealand, and Japan.
  • Track 1 priority filing in the United States.
  • European Patent Office and Eurasian Patent Office issued favorable communications, including notice of intentions to grant.
  • Novelty, inventive step, and industrial applicability fully accepted.

Notable Quotes

• "The company has already confirmed dosage bioequivalence in small-mass (less-than-20-kilogram) animals; however, a large-mass (greater-than-40-kilogram) animal study will provide valuable insight into the appropriate sublingual drug load for humans," said Hugh Rogers, chief executive officer of Bionxt. "This large-mass animal study is expected to increase the formula precision in our human study and is designed to generate comparative drug absorption results between the company's sublingual formulation versus the name-brand tablet formulation. Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative-human bioequivalence study."