Evobrutinib for multiple sclerosis

What was evobrutinib for MS?

Evobrutinib is an oral therapy that was tested in clinical trials as a potential treatment for relapsing forms of multiple sclerosis (MS), but whose development was stopped after negative results in two Phase 3 clinical trials.

Developed by Merck KGaA (known as EMD Serono in the U.S. and Canada), the therapy was specifically tested in people with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

Evobrutinib was designed to target a protein called Bruton’s tyrosine kinase (BTK), which is found on several immune cells, including B-cells and macrophages, involved in the inflammatory processes that drive MS.

By blocking this protein, evobrutinib was expected to reduce disease activity and slow disability progression. But it failed to outperform the approved therapy Aubagio (teriflunomide) on these clinical measures, leading Merck KGaA to discontinue its development in early 2024.

Therapy snapshot

Treatment name	Evobrutinib
Administration	Oral tablets
Clinical testing	Discontinued after it failed to reduce disease activity and disability progression in Phase 3 testing

Evobrutinib in MS clinical trials

Evobrutinib was tested in one Phase 2 and two Phase 3 clinical trials involving more than 2,500 adults with relapsing forms of MS.

The Phase 2 trial (NCT02975349) tested different doses of evobrutinib against a placebo in 267 adults with RRMS and active SPMS. Results showed that the highest doses lowered the total number of lesions observed in MRI scans during weeks 12 through 24. Those doses also significantly reduced relapse rates, by up to 77% after six months, and those rates remained low for up to 3.5 years in an extension phase.
The EVOLUTION RMS 1 (NCT04338022) and EVOLUTION RMS 2 (NCT04338061) Phase 3 studies then tested evobrutinib against Aubagio in 2,290 patients. The main goal was to demonstrate that evobrutinib was superior to Aubagio at reducing relapse rates after up to three years, but that goal was not met. Evobrutinib was also no better than Aubagio at slowing disability progression or reducing brain lesions.

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FAQs about evobrutinib

How does evobrutinib help with multiple sclerosis?

Evobrutinib is a BTK inhibitor designed to reduce the activity of certain immune cells involved in multiple sclerosis (MS), which was expected to reduce disease activity and slow disability progression. However, the drug failed to outperform an approved MS therapy in Phase 3 clinical trials, leading to its discontinuation.

When will the FDA approve evobrutinib?

Evobrutinib is no longer being developed for multiple sclerosis (MS) after it failed to reduce relapse rates, slow disability progression, and prevent the formation of new lesions compared with Aubagio (teriflunomide), an approved medication. For this reason, the drug is not expected to ever be approved by the U.S. Food and Drug Administration for MS.

Can I take evobrutinib while pregnant?

Clinical trials of evobrutinib did not include pregnant or breastfeeding patients, so it is not known whether the therapy is safe for use during pregnancy.

How long should I wait to see the results of evobrutinib?

In a Phase 2 clinical trial that compared evobrutinib against a placebo, a significant reduction in the number of brain lesions was reported after about six months of treatment. However, because each person responds differently to a given medication, it is difficult to predict exactly when someone would start to see benefits from evobrutinib.

Does evobrutinib cause hair loss or weight gain?

Neither hair loss nor weight gain were reported as side effects of evobrutinib in multiple sclerosis clinical trials. Patients who experience unexpected effects after starting a new therapy should talk to their healthcare providers.