07:38 AM EDT, 03/18/2024 (MT Newswires) -- BioNxt Solutions ( BNXTF ) on Monday said that, based on the success of its toxicity and comparative pharmacokinetic (PK) studies, the company is advancing towards human comparative bioavailability studies on an expedited basis.

Sample manufacturing is planned for Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission also planned for Q2 2024.

BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the multiple sclerosis (MS) market. Cladribine tablets are currently approved for use in over 75 countries, including by the US FDA and the European Medicines Agency (EMA. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia.

BioNxt has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.