BioNxt Advances Towards Human Trials with ODF Cladribine for MS

BioNxt Solutions Inc., a life sciences firm, announced the progression towards human comparative bioavailability studies for its Orally Dissolvable Film (ODF) Cladribine product, targeting multiple sclerosis (MS) treatment. Following the success in toxicity and pharmacokinetic studies, the company is now moving towards technology transfer, manufacturing upscaling, and clinical sample preparation—critical steps ahead of human trials slated for rigorous evaluation under European guidelines.

Recent studies have shown positive outcomes, including no observed adverse toxicity in animal trials and promising bioequivalence with the reference drug, setting the stage for the upcoming human comparative bioequivalence study in Europe. BioNxt's Cladribine ODF, aimed at the global MS market, seeks to leverage the existing approval of Cladribine tablets in over 75 countries. With an eye on the significant MS market and the potential of the global Multiple Sclerosis drug market, the company is preparing for patent filings to secure its novel formulation.

The German subsidiary of BioNxt, specializing in non-invasive drug delivery systems, supports the company's strategic endeavors in the pharmaceutical drug delivery market. As the industry projects growth, BioNxt aims to capitalize on its innovative drug formulation and delivery technologies, targeting a substantial market presence in Europe and beyond.