BioNxt Solutions has announced the successful formulation of a sublingual thin-film prototype for its lead clinical stage candidate, BNT23001, using the active pharmaceutical ingredient (API) cladribine.
This proprietary sublingual thin-film formulation is being developed for the treatment of multiple sclerosis (MS).
This formulation milestone strengthens the foundation for clinical batch manufacturing and further optimisation, which are ongoing as part of BioNxt’s strategy to initiate a human bioequivalence study in the second half of 2025.
Promising factors of the cladribine prototype
The cladribine API was used by BioNxt’s European drug development partner, Gen-Plus GmbH & Co. KG, based in Munich, Germany, to develop and produce prototype oral dissolvable films (ODFs).
These initial formulations demonstrated promising characteristics in terms of drug loading, film uniformity, and disintegration time, confirming the suitability of cladribine for thin-film drug delivery.
BNT23001 is designed to offer a patient-centric alternative to conventional oral cladribine tablets, such as Mavenclad®, by delivering the drug through a rapidly dissolving sublingual film.
This approach aims to improve treatment adherence, particularly for MS patients who experience dysphagia, a common symptom that affects the ability to swallow.
The proprietary thin-film platform enables precise and rapid drug absorption via the oral mucosa, offering potential advantages in bioavailability, convenience, and patient experience over traditional oral or injectable formats.
Key milestones in drug development for BioNxt
In parallel with formulation progress, BioNxt continues to advance its intellectual property strategy.
The company believes that continued validation of the product and further experimental data will support additional IP filings, with patent protection representing a key upcoming milestone for BNT23001. BioNxt has already initiated patent nationalisation processes in Europe, the US, and Canada.
Hugh Rogers, CEO of BioNxt Solutions, commented: “The successful formulation of the first cladribine-containing thin-film prototype marks a major step forward in the clinical development of BNT23001.
“It also underscores the strength of our drug delivery platform as we move toward human trials and eventual commercial readiness.”
Next steps
BioNxt expects to continue formulation optimisation and begin in vitro performance testing, with preclinical evaluation to follow as the company advances toward regulatory readiness and potential out-licensing opportunities.
