08:39 AM EDT, 03/13/2024 (MT Newswires) -- BioNxt Solutions Inc. ( BNXTF ) , which lost near 5% yesterday, earlier on Wednesday said that the comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF) based proprietary Cladribine product for the treatment of Multiple Sclerosis (MS) has been completed. The study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine.

BioNxt says the animal PK study results are highly promising and showed comparable rapid absorption and systemic exposure between the company's ODF product and the name-brand reference drug in all samples.

"These results are a significant milestone for BioNxt. We have demonstrated that our ODF platform is an effective drug delivery system for cytostatic drugs via transmucosal absorption," said Hugh Rogers, CEO. "With our recently obtained toxicology data, the PK results allow us to strengthen the company's Cladribine ODF patent position and proceed immediately to a PK study in humans. These exciting results validate the potential for BioNxt to immediately expand into additional ODF drug formulations for similar, high-value and highly toxic drugs."

BioNxt has accelerated its Cladribine ODF program with GMP product development and batch production planned for Q1 and Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2.

The company 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.