Dissolvable film may deliver more MS medicine than standard tablets
Preclinical pig study suggests higher cladribine exposure vs. a tablet form
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Bionxt said its sublingual cladribine film BNT23001 showed about 40% higher exposure than tablets in pigs.
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The dissolvable film approach may offer an option for people with MS who have trouble swallowing pills.
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The company plans human studies to further evaluate the sublingual cladribine formulation.
Bionxt Solutions’ experimental sublingual therapy BNT23001 led to about 40% higher blood exposure to cladribine than a conventional oral tablet formulation, such as those used in multiple sclerosis (MS) therapies like Mavenclad, the company reported.
The results come from a preclinical study in adult miniature pigs, an animal model often used in drug research. Bionxt said the findings support its dissolvable-film approach as a potential alternative, especially for people who may have difficulty swallowing tablets.
“These final preclinical pig study results validate the efficiency of our proprietary sublingual delivery approach and provide quantitative confirmation that our ODF [oral dissolvable film] delivers cladribine more efficiently than conventional oral tablets,” Hugh Rogers, CEO of Bionxt, said in a company press release.
Bionxt plans next steps after preclinical testing
With preclinical testing completed, Bionxt said it plans to move into human studies to compare how BNT23001 behaves in the body against a tablet formulation. The company also said it will continue manufacturing work and prepare regulatory submissions.
“With a meaningful increase in systemic drug exposure demonstrated in a robust non-rodent model, we now have strong scientific justification to advance the sublingual ODF formulation into human [pharmacological] studies as a planned next commercialization step,” Rogers added.
Mavenclad is a short-course oral treatment approved for people with relapsing forms of MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It works by lowering certain immune cells that drive inflammation and damage in MS.
BNT23001 is a thin film designed to dissolve under the tongue. This approach may allow cladribine to be absorbed through the mouth’s lining rather than relying entirely on the digestive system. Bionxt says this could affect how quickly the drug is absorbed.
In earlier preclinical work, Bionxt reported that BNT23001 was rapidly absorbed and produced cladribine exposure comparable to tablets, with no toxicity signals seen after several consecutive days of dosing.
Pig study finds higher cladribine exposure with dissolvable film
Bionxt reported that it ran additional testing in adult miniature pigs. After a single dose, cladribine levels were tracked for 48 hours, and overall exposure was measured using the area under the curve (AUC), a common way to estimate how much drug reaches the bloodstream and how long it remains there.
According to the company, the sublingual film produced a mean cladribine AUC of 39.46 nanogram-hours per milliliter (ng·h/mL), compared with 28.11 ng·h/mL for the oral tablet — an increase of about 40% in overall exposure.
Beyond MS, Bionxt said it is exploring the sublingual film approach for other autoimmune diseases, such as myasthenia gravis, where swallowing difficulties can be common. The company said it also plans to develop dissolvable film versions of other medicines.
