Experimental Autoimmune Drug Shows Benefits in Relapsing Multiple Sclerosis

Merck KGaA recently announced positive results from a phase 2b clinical trial of evoburitnib in relapsing multiple sclerosis (MS), according to a press release.

Evobrutinib, an investigational highly-selective inhibitor of Bruton’s tyrosine kinase (BTK), is in development for MS, rheumatoid arthritis, and systemic lupus erythematosus.

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BTK is crucial for the development and actions of immune cells, making it a target for autoimmune conditions. Evobrutinib is designed to block B cell response without affecting T cells, which are thought to suppress autoantibody-producing cells, according to the release.

In the trial, 267 patients with relapsing MS were randomized to receive treatment with evobrutinib, tecfidera, or placebo for 24 weeks, at which time the placebo cohort was switched to receive evobrutinib.

The researchers found that the trial met its primary endpoint of a clinically meaningful reduction of gadolinium-enhancing TI lesions at weeks 12, 16, 20, and 24 compared with placebo, according to the release.

The ongoing trial is expected to be completed in February 2019, according to Merck KGaA.

Evobrutinib has not been approved for use by any regulatory agency.

"We are encouraged by these early positive results of evobrutinib in relapsing MS," said Luciano Rossetti, head of Global Research and Development at the Biopharma business of Merck KGaA, Darmstadt, Germany. "The trial will continue so as to further inform our clinical development strategy for evobrutinib in MS."