BioNxt Reports Promising Results in ODF Cladribine Study for MS

BioNxt Solutions Inc., based in Vancouver, BC, has announced successful outcomes from its pharmacokinetic (PK) study on an oral dissolvable film (ODF) based Cladribine product designed for treating Multiple Sclerosis (MS). The company highlighted that the study, employing animal models, showcased rapid absorption and systemic exposure of its ODF product comparably to the reference drug.

The CEO of BioNxt, Hugh Rogers, expressed the significance of these findings, conveying how the ODF platform could be an effective medium for cytostatic drug delivery via transmucosal absorption. These results, complemented by recent toxicology data, are set to bolster the company's Cladribine ODF patent stance while paving the way for human PK studies.

BioNxt's current efforts focus on leveraging the ODF technology to create a proprietary hybrid-generic Cladribine form targeting the MS market and potentially other high-value drugs. Cladribine, approved in over 75 countries, presents a significant opportunity given its existing market presence and the global MS drug market's expected growth to USD 41 billion by 2033.

The company has also fast-tracked its Cladribine ODF program, planning for advanced product development phases throughout 2024 and aiming for substantial patent protection extending to 2044. BioNxt's operations span across North America and Europe, specializing in innovative drug delivery systems like transdermal patches and sublingual strips.