- BioNxt completed its comparative pharmacokinetic study for its oral dissolvable film to treat multiple sclerosis
- In a statement, the Vancouver-based company revealed it is developing a proprietary hybrid-generic ODF cladribine dosage form, directed at the MS market
- BioNxt Solutions has filed patent applications for cladribine with three-to-four patent applications expected to be on file in several international jurisdictions later this year into early 2025
- Shares of BioNxt Solutions last traded at $0.60 per share
BioNxt (CSE:BNXT) completed its comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF) to treat multiple sclerosis (MS).
In a statement, the Vancouver-based company revealed it is developing a proprietary hybrid-generic ODF cladribine dosage form, directed at the MS market.
Cladribine tablets have been approved for use in more than 75 countries, including by the U.S. Food and Drug Administration and the European Medicines Agency, for a range of indications including highly active forms of relapsing-remitting multiple sclerosis and certain forms of leukemia.
The PK study was carried out by a European contract research organization with a single administration of either sublingual (ODF) or oral (tablet) cladribine.
BioNxt has accelerated its cladribine ODF program in a priority manner with GMP product development and batch production planned for Q1 and Q2 2024 with the European Investigational Medicinal Product Dossier preparation and submission planned for Q2 2024.
BioNxt Solutions has filed patent applications for cladribine with three-to-four patent applications expected to be on file in several international jurisdictions later this year into early 2025. It also has the potential for patent protection extending into 2044.
An estimated 90,000 Canadians have multiple sclerosis and Canada has one of the highest rates of MS in the world, according to MS Canada. Instances of MS occur more frequently at higher latitudes of the globe.
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation.
Shares of BioNxt Solutions last traded at $0.60 per share.
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