Bionxt Solutions Nears Human Trials with Key Drug Delivery Advance

Bionxt Solutions CA0909741062

The biotechnology firm Bionxt Solutions is preparing to enter a pivotal new stage of development. Following encouraging preclinical data, the company is set to advance its lead program—a novel formulation of Cladribin for treating Multiple Sclerosis—into human clinical testing. In a parallel strategic move, Bionxt is expanding its pipeline to target a second autoimmune condition.

Bionxt’s development approach is designed to be capital-efficient by focusing on a new delivery method for an already-approved drug. Cladribin is an established active ingredient; Merck’s product Mavenclad® generated over $1 billion in revenue in 2024. Rather than conducting extensive new safety and efficacy trials from scratch, Bionxt is concentrating its efforts on demonstrating the bioequivalence of its proprietary formulation. The company is collaborating with an experienced clinical research organization to support study design and regulatory processes, with R&D activities spanning North America and Europe and a primary commercial focus on European markets.

Preclinical Data Shows Significant Bioavailability Gain

A key milestone was reached in late January 2026 when the Vancouver-based company released final results from a preclinical study conducted on pigs. The data revealed that its sublingual thin film (Oral Dissolvable Film, or ODF) delivery of Cladribin achieved approximately 40% higher systemic bioavailability compared to conventional oral tablets.

This measurement, based on the standard pharmacokinetic metric AUC (Area Under Curve) which tracks drug concentration in the body over 48 hours, significantly de-risks the path forward for clinical development, according to the company. The ODF technology allows the drug to dissolve under the tongue, where it is absorbed directly into the bloodstream through the oral mucosa. This offers a needle-free and patient-friendly alternative to injections or standard pills.

Pipeline Expansion Targets Myasthenia Gravis

Concurrently, Bionxt announced it will develop its Cladribin technology for Myasthenia Gravis (MG), a rare neuromuscular autoimmune disorder estimated to affect 1.4 million people globally. A core symptom of MG is dysphagia, or difficulty swallowing, which complicates the administration of conventional tablets. Bionxt believes its sublingual film presents a clear advantage for these patients.

The market opportunity is substantial. Analysis from GlobalData projects the market for MG therapeutics to grow to approximately $6.7 billion USD by 2032. For comparison, the Multiple Sclerosis treatment market is estimated to reach $41.2 billion by 2034.

Shares Face Pressure as Critical Phase Begins

As of January 27, Bionxt shares were trading at €0.37, marking a notable daily decline. Since the start of the year, the equity has recorded a loss of roughly 9%. The company now enters a decisive period where clinical development must confirm whether the promising preclinical data can be successfully replicated in human subjects.

@ boerse-global.de | CA0909741062 BIONXT