Bionxt Solutions Advances Multiple Sclerosis Drug Delivery Program

Biotechnology firm Bionxt Solutions is accelerating the development of its innovative drug delivery technology, with a key program targeting Multiple Sclerosis (MS) now moving closer to human trials. This follows encouraging preclinical results for its oral film formulation.

On January 26, Bionxt announced plans to advance its MS program into human clinical testing. This decision was driven by data from a preclinical study released just five days earlier. The company is now preparing a human bioavailability and bioequivalence study. Success in this phase would represent a significant milestone toward potential regulatory approval for the new delivery method.

Preclinical Data Shows Enhanced Absorption

The recently completed study evaluated a sublingual film containing the established MS therapy Cladribin. Tested on a larger, non-rodent animal model, the film placed under the tongue demonstrated a clinically relevant advantage: it achieved approximately 40% higher systemic drug concentration compared to a conventional oral tablet.

This increased bioavailability is significant. It suggests that a lower dose of the medication could be effective, or that a standard dose could yield a more potent therapeutic effect, potentially improving patient treatment.

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The Platform Technology Strategy

Bionxt is focused on creating targeted drug delivery platforms. Its pipeline includes not only the sublingual thin-film technology but also a system designed for targeted chemotherapy administration.

The company’s commercial strategy involves developing these technology platforms and then bringing them to market through licensing agreements or partnerships. This approach is intended to accelerate commercialization without Bionxt having to manage every step of development and distribution independently.

The positive preclinical outcome substantially de-risks the upcoming clinical phase for the MS program, marking a pivotal step forward for the company's platform.