BioNxt Completes IMPD for Multiple Sclerosis Drug Program

BioNxt Solutions Inc., a bioscience firm focusing on innovative drug delivery systems, announces the completion of the Investigational Medicinal Product Dossier (IMPD) for its BNT23001 cladribine oral dissolvable film (ODF). This marks a significant regulatory advance in its development program for treating relapsing multiple sclerosis (MS).

The IMPD consolidates comprehensive pharmaceutical, manufacturing, analytic, non-clinical, and clinical documentation necessary for regulatory review. It is undergoing final technical checks before submission as part of BioNxt's Clinical Trial Application in Europe.

Key achievements include completion of GMP manufacturing and successful preclinical evaluations. The planned clinical trial will assess bioequivalence to the current reference product, Mavenclad®, comparing efficiency, safety, and tolerability in healthy volunteers.

BioNxt's oral film platform aims to simplify drug delivery for patients with swallowing difficulties, offering a patient-centered, needle-free alternative.