BioNxt Completes IMPD for Multiple Sclerosis Treatment

BioNxt Solutions Inc. has announced the completion of the Investigational Medicinal Product Dossier (IMPD) for its sublingual cladribine oral dissolvable film, BNT23001. This development marks a significant regulatory milestone for BioNxt's leading multiple sclerosis treatment candidate. The dossier, essential for clinical trial applications in Europe, is currently under final review.

The IMPD integrates pharmaceutical, manufacturing, and clinical documentation. It is a crucial step toward BioNxt's first human bioequivalence study. Preparation of the dossier involved collaboration with pharmaceutical development partners. Completion of this comprehensive dossier reflects BioNxt's progress in formulation development, GMP manufacturing, and regulatory documentation.

Pending approval, BioNxt plans to submit a clinical trial application for a study comparing BNT23001 with Mavenclad®, aiming to evaluate bioequivalence and assess safety. This product utilizes BioNxt's oral dissolvable film technology designed for rapid and needle-free delivery, especially beneficial for patients with swallowing difficulties, like those with multiple sclerosis.