BioNxt Launches 15-day Sublingual Cladribine Dosing Optimization Study in Preparation for Human Bioequivalence Study

Executive Summary

• BioNxt Solutions announced the commencement of a large‑mass animal bioequivalence study for its lead sublingual cladribine product (BNT23001), the final preclinical step before a human comparative bioequivalence trial slated for early 2026.
• The 15‑day crossover study will begin within two to three weeks, conclude in November, and results are expected by December, providing dosing parameters and absorption data critical for human trial design.
• Patent nationalization efforts continue across major markets (EU, Canada, Australia, Eurasia, New Zealand, Japan, and the United States), with favorable communications from the European and Eurasian patent offices indicating likely grant approvals.

Key Details

• Study Scope: Large‑mass (>40 kg) animal crossover bioequivalence study to compare sublingual BNT23001 against the branded tablet formulation.
• Timeline: Study start in 2–3 weeks; duration 15 days; completion expected November 2025; results anticipated December 2025.
• Objective: Generate dosing parameters, optimize drug load per dose, and assess potential super‑bioavailability to inform the human comparative bioequivalence study planned for early 2026.
• Previous Findings: Bioequivalence already confirmed in small‑mass (<20 kg) animals; high absorption rates and no toxicity observed in preclinical work.
• Product Description: BNT23001 is an orally dissolvable thin‑film sublingual formulation of cladribine aimed at improved bioavailability, faster onset, and better patient compliance for multiple sclerosis treatment.
• Patent Activity: Ongoing national filings in EU, Canada, Australia, Eurasia, New Zealand, Japan; Track One priority filing in the U.S.; favorable communications from EPO and Eurasian Patent Office indicating intent to grant.

Notable Quotes

“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.” – Hugh Rogers, CEO

Materiality Assessment: Material – Positive (the announcement advances a key development milestone that materially impacts future clinical planning and potential commercialization).