BioNxt Solutions Inc. has announced the receipt of its thin-film formulation of sublingual cladribine (BNT23001) for the treatment of multiple sclerosis (MS).
The delivery of the cladribine API enables the commencement of clinical batch manufacturing in collaboration with BioNxt’s European contract research and development partner, Gen-Plus GmbH & Co KG, based in Munich, Germany.
This milestone supports the company’s plan to initiate a human bioequivalence study in the second half of 2025.
A patient-friendly alternative to oral cladribine tablets
BioNxt’s sublingual cladribine solution is designed to offer a patient-friendly alternative to traditional oral cladribine tablets, such as Mavenclad®, by providing a rapidly dissolving sublingual film.
This delivery method aims to enhance patient compliance, particularly for individuals with MS who experience dysphagia, a common symptom affecting the ability to swallow.
Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse toxic effects observed.
These findings support the progression to human bioequivalence studies.
Progress in securing patents
BioNxt has also made significant strides in securing intellectual property rights for BNT23001.
The company has initiated patent nationalisation processes in key jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated by mid-2025.
“The receipt of the cladribine API is a pivotal step forward in our mission to develop innovative, patient-centric therapies for MS,” said Hugh Rogers, CEO of BioNxt Solutions.
“We are committed to advancing BNT23001 through clinical development and bringing this novel treatment option to patients worldwide.”
