Multiple Sclerosis Society of Canada

Evobrutinib

Overview:

Also known as: M2951
Pharmaceutical Company: EMD Serono
Route and Dose of Administration: Oral (25-120 mg daily)
Type: Immunomodulator
Emerging Treatment for: Relapsing Multiple Sclerosis (RMS)
Status: In Phase III clinical trial

How it works

Evobrutinib selectively inhibits a protein called Bruton’s tyrosine kinase or BTK, in order to reduce the activation of B cells that contribute to brain and spinal cord inflammation in MS. Since B cells can also activate T cells to further enhance the inflammatory process in MS, inhibition of BTK by evobrutinib can indirectly reduce T cell function.

Research and Results

Phase II Trial

A phase II, double-blind, placebo-controlled clinical trial recruited 267 people with relapsing MS to examine the safety and effectiveness of evobrutinib compared with Tecfidera (dimethyl fumarate). Participants were randomized to receive either Tecfidera or three different doses of evobrutinib (25 mg once daily, 75 mg once daily, or 75 mg twice daily) for 48 weeks. Updated trial results presented at the 2019 American Academy of Neurology conference indicated that compared to placebo, the higher doses of evobrutinib significantly reduced brain lesions in study participants after 24 weeks of treatment. Furthermore, no relapses were observed in 79% of participants who received the highest treatment dose (75 mg evobrutinib twice daily) after 48 weeks. The most common side effects of evobrutinib treatment were cold-like symptoms and increased liver enzymes.

The trial is currently active but not recruiting. The anticipated study completion date is February 2025.

Phase III Trial: evolutionRMS1 and evolutionRMS2

evolutionRMS1 and 2 are phase III, randomized, double-blind, multi-center clinical trials testing the efficacy of evobrutinib compared with Aubagio (teriflunomide). Both trials are recruiting 930 adults that will be randomly assigned to receive either oral evobrutinib (twice daily) or oral Aubagio (once daily) for 96 weeks. The primary outcome measures will evaluate changes in annualized relapse rates between the two treatment groups. The trials will also measure time to confirmed disability accumulation, total number of gadolinium-enhancing lesions, and total number of new or enlarging T2 lesions.

The trial is currently active but not recruiting. The anticipated completion date for both trials is July 2026.

References:

Montalban X et al. Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis. N Engl J Med. 2019; 380: 2406-2417.

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