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July 18, 2024


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Explaining biotech: Bionxt Solutions (BNXT.C) advances MS product through animal study

Bionxt Solutions Inc. (BNXT.C) has finished a study on a new type of medicine strip that dissolves in your mouth. This strip is designed to treat multiple sclerosis (MS), a condition that affects the brain and nerves. The study looked at how well and how quickly the body absorbs the medicine from this strip compared to traditional ways of taking the drug.

Key points from the study and related developments include:

  • Promising Study Results: The animal PK study showed that Bionxt’s Oral Dissolvable Film (ODF) Cladribine product has rapid absorption and systemic exposure comparable to the reference drug. The study’s findings show that the company’s mouth-dissolving strip works well for delivering cancer-slowing drugs into the body through the tissues inside the mouth..
  • Strategic Advancements: CEO Hugh Rogers emphasized the significance of these findings, stating they validate the potential for Bionxt to expand its ODF drug formulations. The positive pharmacokinetic (PK) and toxicology data strengthen the patent position of Cladribine ODF and pave the way for human PK studies.
  • Market Potential: Bionxt is targeting the MS market with its proprietary ODF Cladribine dosage form. Cladribine tablets are widely approved and generate over $1 billion in annual sales. With approximately 2.3 million people living with MS globally, the MS drug market is expected to reach $41 billion by 2033.
  • Regulatory and Development Plans: Following successful animal studies, Bionxt is fast-tracking its Cladribine ODF program. This includes GMP product development, batch production, and the preparation and submission of a European Investigational Medicinal Product Dossier (IMPD) within 2024.
  • Intellectual Property: Bionxt has filed provisional patent applications for its Cladribine ODF technology, with plans to file additional applications in major international jurisdictions. Patent protection could extend to 2044, securing the company’s position in the market.
  • Company Background: Bionxt’s wholly owned subsidiary in Germany specializes in non-invasive drug delivery systems, such as transdermal patches and sublingual strips. The global pharmaceutical drug delivery market, valued at $1,525 billion in 2022, is projected to grow significantly by 2030.

These developments underscore Bionxt’s commitment to innovating in the drug delivery space, specifically for MS and potentially other high-value, highly toxic drugs.

— Equity Guru

Disclosure: We own stock in BNXT

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