- Preclinical studies show high absorption rates and bioequivalence to existing treatments.
- Study completion expected in under 30 days once started.
- Key materials (Cladribine API) already acquired for technology transfer.
BioNxt Solutions Inc. (CSE:BNXT, OTC:BNXTF) is advancing preparations for a human bioequivalence study of its lead Multiple Sclerosis treatment, BNT23001. The proprietary sublingual thin-film formulation of Cladribine is designed to offer a more convenient and effective treatment option for MS patients.
The company has secured the necessary Cladribine active pharmaceutical ingredient, facilitating the technology transfer with Gen-Plus, its European Contract Research and Development Organization based in Munich, Germany. The bioequivalence study, once initiated, is slated to be completed in less than 30 days.
Preclinical studies conducted by BioNxt have reported high absorption rates and bioequivalence when compared to existing oral tablet therapies. BNT23001's sublingual thin-film configuration promises several advantages, including ease of administration, rapid absorption through sublingual mucosa, and enhanced patient compliance.
BNT23001 is expected to address some of the limitations associated with traditional oral therapies. By delivering a convenient and portable solution, BioNxt aims to improve patient adherence and outcomes for individuals living with chronic conditions such as Multiple Sclerosis.
BioNxt Solutions Inc. continues to focus on next-generation drug delivery technologies and is working towards regulatory approvals and commercialization, particularly in European markets. The company is committed to enhancing healthcare solutions by providing patient-centric treatments.
