Bionxt prepares for clinical trial testing sublingual cladribine for MS
Treatment would be alternative to Mavenclad tablets
Bionxt Solutions is getting ready to launch a pilot clinical trial to test BNT23001, its sublingual (under-the-tongue) version of cladribine to treat multiple sclerosis (MS).
The treatment would be an alternative to Mavenclad, the approved tablet form of cladribine.
Bionxt‘s thin-film formulation quickly dissolves under the tongue, providing an alternative method of administration for people with MS who have difficulty swallowing (dysphagia), a common MS symptom.
The company said it has secured the necessary active pharmaceutical ingredient (cladribine) to be used by its development partner, Gen-Plus, to manufacture BNT23001 for the upcoming human bioequivalence study, according to a company press release,
The study aims to build on successful preclinical results and confirm whether the new formulation has a similar safety profile and delivers the medication into the bloodstream at a rate and extent equivalent to its tablet counterpart.
Study of cladribine for MS to take 30 days, company says
Bionxt said it will provide further updates on study preparation and the timeline “in the coming weeks.” Once underway, the study is expected to be completed within 30 days, the company said.
Mavenclad is approved to treat relapsing forms of MS and is marketed in the U.S. by EMD Serono (known as Merck KGaA outside North America).
It works by selectively reducing the number of certain immune cells in the bloodstream, specifically T-cells and B-cells, which are key drivers of inflammation and damage to the protective myelin sheath around nerve cells in MS.
The treatment follows a short-course schedule over two years. Each year includes two treatment cycles, each lasting no more than five consecutive days and spaced about a month apart. After completing this two-year regimen, no further treatment is required for at least another two years.
This dosing schedule offers a more convenient alternative to many other disease-modifying therapies (DMTs) for MS, which may require daily, weekly, or monthly dosing on a continuous basis.
Clinical trials have demonstrated that Mavenclad leads to long-term reductions in MS disease activity and disability accumulation, with benefits sustained for several years after treatment. A follow-up study found that more than half of patients who received Mavenclad during clinical trials did not require additional DMTs for nearly 11 years after their initial treatment.
Bionxt is developing BNT23001 to offer a more accessible treatment option to MS patients who might have swallowing issues.
Because it dissolves quickly and is absorbed directly into the bloodstream, thereby avoiding passage through the gastrointestinal tract, BNT23001 is also expected to act faster than the traditional tablet form. Its simple, user-friendly formulation may also help improve adherence to treatment, Bionxt says.
Preclinical studies in animal models have shown that BNT23001 has comparable pharmacological properties to Mavenclad, with rapid absorption and similar levels of cladribine detected in the bloodstream. No signs of toxicity were observed even after consecutive days of dosing, supporting its safety profile.
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