BioNxt Solutions Achieves Key Preclinical Milestone for Oral Patch

Bionxt Solutions CA0909741062

BioNxt Solutions Inc. has reported a significant preclinical breakthrough for its innovative drug delivery system. The company's proprietary sublingual oral patch formulation of cladribine, developed for treating multiple sclerosis (MS), demonstrated a bioavailability increase exceeding 40% compared to standard oral tablets. This compelling data paves the way for upcoming human clinical trials and has prompted the firm to expand its development program into a second therapeutic area.

Encouraged by the strong preclinical results, BioNxt is now advancing its cladribine patch program for the treatment of myasthenia gravis (MG). This rare, chronic autoimmune disorder, affecting an estimated 1.4 million people globally, causes muscle weakness that often impairs swallowing, speaking, and chewing. The sublingual patch could offer a viable alternative for MG patients who experience difficulty with conventional pills. Market research firm GlobalData projects the MG treatment market across seven major countries will reach approximately $6.7 billion by 2032.

Analysis of the Preclinical Trial Data

In a study conducted using mature Göttingen minipigs—a pharmacologically established model due to physiological similarities to humans—BioNxt compared its sublingual buccal film to an approved generic cladribine tablet. The key pharmacokinetic metric, the area under the curve (AUC), which measures systemic drug exposure, was 39.46 ng·h/mL for the patch. This contrasted with a reading of only 28.11 ng·h/mL for the oral tablet, quantifying the superior drug absorption. The enhanced bioavailability, measured over a 48-hour period, is attributed to the patch's ability to bypass hepatic first-pass metabolism, potentially leading to a more efficient treatment profile.

Pathway to Human Trials and Regulatory Strategy

The Vancouver-based company is collaborating with an experienced clinical research organization to prepare for its first-in-human study. Current efforts are concentrated on clinical planning, manufacturing readiness, and regulatory alignment. Because cladribine is already an approved active pharmaceutical ingredient, BioNxt is not required to conduct extensive new safety and efficacy studies. Instead, the clinical work will focus on demonstrating bioavailability and bioequivalence, representing a notably faster development pathway to market.

Market Context and Corporate Progress

The broader market opportunity is substantial. For multiple sclerosis, GlobalData estimates a global market value across 68 countries of $32.8 billion for 2024. Merck KGaA's approved cladribine product, Mavenclad®, generated over $1 billion in revenue in 2024, underscoring the commercial potential of the drug class.

BioNxt has recently achieved several intellectual property milestones, including a final patent grant from the Eurasian Patent Organization and an "Intention to Grant" notice from the European Patent Office. Furthermore, in September 2025, the company completed an uplisting to the OTCQB Venture Market.

With human clinical testing imminent, the potential market readiness of its lead candidate, BNT23001, draws closer. The strategic expansion into myasthenia gravis demonstrates the company's plan to leverage its platform technology to address multiple high-value indications.