BioNxt Solutions Advances BNT23001 for MS Treatment

BioNxt Solutions Inc. has reported significant progress in developing BNT23001, a sublingual thin-film formulation of Cladribine, for Multiple Sclerosis treatment. In 2024, the company achieved critical milestones that support the initiation of clinical trials in 2025.

Preclinical studies have shown high absorption rates of Cladribine in animal models, confirming its bioequivalence to Mavenclad®. Toxicity studies revealed no adverse local effects. Manufacturing processes have been transferred to Gen-Plus GmbH & Co KG, preparing for clinical batch production.

BioNxt has also strengthened its intellectual property position, with patent nationalization underway in key regions. The company plans to submit regulatory filings by mid-2025 and conduct a pilot clinical study comparing BNT23001 to Mavenclad®.

BNT23001 aims to improve convenience and compliance, offering a patient-friendly alternative for MS management through rapid sublingual absorption.