- BioNxt Solutions (OTC:BNXTF) successfully develops cladribine sublingual thin-film prototype for multiple sclerosis treatment.
- The company plans human bioequivalence studies for BNT23001 in the second half of 2025.
- Patent nationalization processes initiated in Europe, the United States, and Canada.
BioNxt Solutions (OTC:BNXTF), a leader in advanced drug delivery systems, has announced the successful formulation of a prototype sublingual thin-film formulation for its cladribine-based therapy, BNT23001. Developed in collaboration with the European partner Gen-Plus GmbH, the prototype showcases promising characteristics in drug loading, film uniformity, and disintegration time, marking a significant milestone in the treatment of multiple sclerosis (MS).
This innovative thin-film format is designed as an alternative to conventional oral tablets, like Mavenclad®, targeting MS patients who suffer from dysphagia. BioNxt plans to initiate human bioequivalence studies in the second half of 2025, as part of their strategy to make BNT23001 a patient-centric solution.
In line with this progress, BioNxt is advancing its intellectual property strategy with patent nationalization processes already underway in Europe, the United States, and Canada. This step is aimed at securing patent protection for their proprietary thin-film platform, which offers advantages in bioavailability, convenience, and patient experience over traditional treatment formats.
Hugh Rogers, CEO of BioNxt Solutions, emphasized the importance of this development, noting that the successful formulation strengthens the company's position as they prepare for further clinical evaluations and regulatory processes. BioNxt remains focused on optimizing the formulation and conducting preclinical evaluations to ensure regulatory readiness and explore potential out-licensing opportunities.
