Leading bioscience accelerator BioNxt Solutions Inc. is pioneering a cutting-edge oral dissolvable Cladribine product for the treatment of Multiple Sclerosis (MS).
The Company recently acquired 100% Cladribine-related IP and has now launched a development and commercialisation programme of a proprietary oral dissolvable film (ODF) based Cladribine product for treating neurodegenerative diseases, most notably MS.
BioNxt drives bioscience innovations, emphasising next-gen drug formulations, POC diagnostic screening tests, and novel pharmaceutical production methods.
Their specialties include precision transdermal and oral dissolvable drugs, affordable infectious disease and oral health screening tests, and clinical assessment of new neurological pharmaceutical ingredients.
With R&D facilities in North America and Europe, primarily operating in Germany, the Company is dedicated to obtaining regulatory approval and launching medical products in European markets.
BioNxt’s focus now turns to its exciting ODF-based Cladribine product, which holds the potential to transform the treatment landscape for the 2.3 million people living with MS worldwide.
What is Cladribine?
Cladribine is a medication that, for the past decade, has been primarily used to treat specific types of leukaemia. In recent years, the medication was rediscovered and repurposed as an effective therapy for MS.
Introduced by a leading pharmaceutical company in Europe in 2017 and in the US in 2019, Cladribine tablets achieved worldwide sales exceeding $1bn by 2022, boasting a three-year compound annual growth rate (CAGR) of 18%.
Cladribine tablets have also obtained approval for use in more than 75 countries, including endorsement by regulatory bodies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) across various medical indications.
How BioNxt is advancing MS treatment
BioNxt’s ODF Cladribine formulation is expertly engineered to offer numerous advantages compared to traditional tablet forms.
Its key anticipated benefit lies in rapid dissolution within the oral cavity, facilitating swift absorption into the bloodstream, thus bypassing potential limitations in absorption within the stomach and upper intestine.
This presents the potential for enhanced dosing accuracy and efficacy, potentially allowing for a lower daily and overall dose regimen for patients.
Moreover, the Company acknowledges the broader applicability of ODFs compared to tablets, particularly among dysphagic patients—those who have difficulty swallowing or are unable to swallow—representing over 40% of MS patients.
Exceptional oral toxicity results
BioNxt recently announced the completion of the toxicity study for the proprietary Cladribine product.
The study, conducted in accordance with EU medical regulatory guidelines by a European contract research organisation, demonstrated unanimous success, with no adverse effects observed in the study’s animal models over five consecutive days of dosing.
Observation included general health monitoring, food intake assessment, and application site examination, revealing no treatment-related toxicity.
Comparative pharmacokinetic studies in animal models have begun in Europe, with results expected in Q1 2024. GMP product development and batch production are slated for Q1 and Q2 2024, with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2 2024.
The Company has filed provisional patent applications for Cladribine ODF protection, expecting three to four patent applications to be lodged in major international jurisdictions by late 2024 to early 2025, potentially extending patent protection until 2044.
