Bionxt Solutions is set to launch a pilot clinical trial to compare its new sublingual formulation of cladribine, BNT23001, with the original oral medication Mavenclad for the treatment of multiple sclerosis (MS). The trial is scheduled to begin in the second half of 2025.
Addressing Dysphagia in MS Patients
Mavenclad, an oral tablet formulation of cladribine, is already approved for adults with relapsing forms of MS. Bionxt's sublingual film, BNT23001, is designed to dissolve under the tongue, offering an easier administration method for patients experiencing dysphagia, a common symptom of MS. This new formulation aims to improve patient convenience and adherence to treatment.
The company intends to evaluate the safety and efficacy of BNT23001 against Mavenclad, while also determining if the sublingual formulation achieves comparable cladribine levels in the bloodstream. According to a company press release, Bionxt is collaborating with a manufacturing partner to ensure the drug is produced and tested according to good manufacturing practices. The first clinical trial batches are expected in the second quarter of 2025, with plans to file for clinical trial approval in Europe by mid-year.
Patent Strategy and Formulation Advantages
Bionxt is also actively seeking patent protection for its proprietary sublingual thin-film formulation in major markets, including Europe, the U.S., and Canada, with patents anticipated by mid-2025.
Mavenclad, marketed in the U.S. by EMD Serono (Merck KGaA outside North America), is an oral treatment that reduces specific immune cells driving inflammation in MS. The treatment involves short courses over two years, with two treatment cycles per year, each lasting no more than five days. Clinical trials have demonstrated long-term reductions in MS disease activity and disability progression over several years.
Potential for Faster Action
Beyond ease of use, BNT23001 may offer a faster onset of action compared to Mavenclad. Because it dissolves quickly and is absorbed directly into the bloodstream, bypassing the gastrointestinal system, the sublingual formulation could potentially lead to quicker therapeutic effects.
According to Bionxt's website, "Leveraging advanced oral dissolvable film technology, BNT23001 provides a convenient, fast-acting, and patient-friendly solution that addresses a critical gap in the MS treatment landscape."
Preclinical studies in animal models have indicated that BNT23001 exhibits comparable pharmacological properties to Mavenclad, with rapid absorption and similar bloodstream levels. No toxicity signs were observed after multiple days of dosing. Bionxt stated that "BNT23001 aligns with BioNxt’s mission to improve outcomes for patients living with chronic diseases like MS."
