BioNxt’s BNT23001 for MS enters final animal test before human trials
Study will compare sublingual version of cladribine with approved tablet
Bionxt Solutions has launched the final animal study needed to prepare for human testing of BNT23001, its sublingual version of cladribine, in people with multiple sclerosis (MS).
The 15-day dosing optimization study will compare Bionxt’s thin-film formulation with the approved tablet version of cladribine, sold as Mavenclad, in large animals weighing more than 40 kg (about 88 lbs). The study is expected to finish next month, with results anticipated in December.
Its goal is to fine-tune the drug load per dose and gather data on how the sublingual version, which is taken under the tongue, is absorbed into the bloodstream. Those findings will guide dose selection and clinical planning for Bionxt’s upcoming human bioequivalence study, which is expected to begin early next year.
Previous testing in smaller animals weighing less than 20 kg (44 lbs) showed that the formulation could deliver a comparable amount of active drug to Mavenclad.
“The company has already confirmed dosage bioequivalence in small-mass … animals; however, a large-mass … animal study will provide valuable insight into the appropriate sublingual drug load for humans,” Hugh Rogers, CEO of BioNxt, said in a company press release. “Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative human bioequivalence study.”
BNT23001 designed to dissolve quickly under the tongue
BioNxt’s sublingual film is designed to dissolve quickly under the tongue, offering faster absorption and potentially higher drug availability in the bloodstream.
This simple and more convenient method of administration could also improve adherence to treatment, especially among people who have swallowing difficulties, known as dysphagia, or who prefer to avoid taking pills.
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 selectively lowering the number of immune T-cells and B-cells, which drive inflammation and damage in MS.
The therapy is given for up to 20 treatment days, spread over the course of two years. Each year of treatment includes two cycles where patients receive treatment for 4 to 5 days, stay off treatment for about one month, and then receive treatment for another 4 to 5 days.
After completing this two-year regimen, no further treatment is required for at least another two years.
This intermittent dosing schedule makes Mavenclad a more convenient alternative to other disease-modifying therapies that often require continuous daily, weekly, or monthly dosing.
Long-term clinical data have shown that Mavenclad can sustain reductions in disease activity and disability progression for several years. In fact, research has demonstrated that many patients did not need further treatment for nearly a decade after initial dosing.
The company’s upcoming bioequivalence study in people with MS will compare how much of the active ingredient reaches the bloodstream when patients receive either the new formulation or Mavenclad. It will also assess the rate of absorption for the two formulations.
If clinical testing confirms that the sublingual formulation performs as well as or better than the tablet form, it could represent a more comfortable and accessible option for people taking cladribine.
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