Clinical trial testing sublingual cladribine planned for next year
Formulation to be compared to MS treatment Mavenclad
Bionxt Solutions is preparing to launch a pilot clinical trial to compare BNT23001, its new sublingual, or under-the-tongue, formulation of cladribine, to the original medication Mavenclad to treat multiple sclerosis (MS).
Mavenclad is a tablet formulation of cladribine that’s approved for adults with relapsing forms of MS. The sublingual film, which dissolves when placed under the tongue, is designed to offer an easier mode of administration for patients with swallowing difficulties (dysphagia), a common MS symptom.
Bionxt aims to start the trial in the second half of 2025, according to a company press release. It seeks to compare the safety and efficacy of the two formulations, and to determine if the amount of cladribine that reaches the bloodstream with the sublingual formulation matches the levels achieved with Mavenclad.
The company said it’s working with a manufacturing partner to ensure the medicine is manufactured and tested in accordance with good manufacturing practices. The first clinical trial batches are expected to be ready in the second quarter of 2025, and the company plans to file for clinical trial approval in Europe by mid-year.
Meanwhile, Bionxt is taking steps to secure patents for its proprietary sublingual thin-film formulation in major jurisdictions, including Europe, the U.S., and Canada. These patents are also anticipated in mid-2025.
New formulation aims for convenience, speed
Mavenclad, sold in the U.S. by EMD Serono (known as Merck KGaA outside North America), is an oral treatment designed to reduce the amount of certain immune cells that are main drivers of inflammation in MS.
The short-course oral treatment is given over two years in two treatment cycles per year, each consisting of no more than five days of treatment. In clinical trials, this has provided long-term reductions in MS disease activity and disability progression over several years.
Bionxt is developing a sublingual formulation that is more convenient for people with swallowing issues. Because it dissolves quickly and is absorbed directly into the bloodstream, bypassing the gastrointestinal system, BNT23001 is also expected to act faster than its brand-name counterpart.
“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,” Bionxt says on its website.
Preclinical studies in animal models showed that BNT23001 had comparable pharmacological properties to Mavenclad, being rapidly absorbed and reaching levels in the bloodstream comparable to the original formulation. No signs of toxicity were reported after consecutive days of dosing.
“BNT23001 aligns with BioNxt’s mission to improve outcomes for patients living with chronic diseases like MS,” the company said.
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