- BioNxt Solutions (OTC:BNXTF) prepares for clinical batch manufacturing of its MS treatment BNT23001.
- Human bioequivalence study for the sublingual cladribine film planned for H2 2025.
- Initiated patent processes in key markets with grants expected by mid-2025.
BioNxt Solutions Inc. (OTC:BNXTF), a leader in innovative drug delivery systems, has announced a major advancement in its multiple sclerosis (MS) treatment program. The company has received the active pharmaceutical ingredient (API) for BNT23001, its proprietary sublingual thin-film formulation of cladribine.
Following this milestone, BioNxt will commence clinical batch manufacturing in collaboration with its European partner, Gen-Plus GmbH & Co KG, based in Munich, Germany. This step is crucial as it sets the stage for a human bioequivalence study planned for the second half of 2025.
BNT23001 is specifically designed to offer a rapidly dissolving sublingual film as an alternative to traditional oral cladribine tablets like Mavenclad®. This is particularly beneficial for MS patients experiencing dysphagia, a common symptom that affects swallowing.
Preclinical studies have shown promising results, indicating high absorption rates and bioequivalence to existing oral therapies, with no observed toxic effects. These outcomes support the transition to human testing phases.
In its pursuit to solidify intellectual property rights, BioNxt has started patent nationalization processes in key jurisdictions, including Europe, the United States, and Canada. The company anticipates patent grants by mid-2025, reinforcing its commitment to advancing patient-centric therapies.
"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."
