BioNxt Reports Successful Final In-Vivo Dosing Study Results Supporting Superior Bioavailability of Cladribine Sublingual ODF

Executive Summary

• BioNxt Solutions completed a comparative pharmacokinetic (PK) study in pigs showing superior bioavailability of its cladribine orally dissolving film (ODF) versus the reference tablet.
• The company will conduct internal analysis of the full dataset and plans to use the results to inform dosing for an upcoming human bioequivalence study.
• Patent protection for the cladribine ODF program is expected to be finalized shortly, strengthening IP position and partnering potential.

Key Details

• Study design: Crossover PK study in adult pigs (40‑50 kg), comparing 10 mg cladribine ODF with a 10 mg reference tablet administered at an equivalent 5 mg dose per animal.
• Administration: ODF placed sublingually; reference tablet given by oral gavage.
• Sampling: Blood collected pre‑dose and at multiple time points over 24 hours to assess peak concentration (Cmax), overall exposure (AUC), and elimination profile.
• Outcome: Preliminary results indicate superior bioavailability for the ODF, suggesting more efficient drug delivery and potential for lower systemic exposure.
• Timeline: Study conducted Nov–Dec 2025; final dataset received Dec 2025; internal screening and full analysis underway.
• Strategic implication: Enhanced delivery efficiency may reduce dose‑related side effects and improve patient tolerability for cladribine therapy in Multiple Sclerosis (MS).
• Market context: MS market projected > US$41 billion by 2033; current cladribine tablet (Mavenclad®) has > US$1 billion annual sales.
• Patent status: Core patent protection confirmed; final national‑level grants expected shortly.
• Next steps: Complete internal data analysis, calculate full PK parameters, and disclose detailed results in a future update; prepare for human bioequivalence study.

Notable Quotes

“We are extremely encouraged by the successful outcome of this study,” said Hugh Rogers, CEO of BioNxt. “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.”