Investigational MS Therapy Showed Positive Results in Phase 2 Study

OCTOBER 23, 2018
Jennifer Barrett, Associate Editor
New data from the investigational multiple sclerosis (MS) drug evobrutinib showed that the therapy reduced lesions and decreased annual relapse rates in patients with relapsing MS, according to a phase 2 study.
Based on the analysis, evobrutinib is the first Bruton’s tryosine kinase (BTK) inhibitor to show clinical proof-of-concept in relapsing MS, according to a Merck press release. The 24-week data results were announced at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany.

The study included an open-label reference arm with dimethyl fumarate (240 mg BID), with no formal statistical comparisons between dimethyl fumarate and evobrutinib or placebo.
In the trial, 244 patients completed 24 weeks of treatment. Patients treated with evobrutinib 75 mg QD (once-daily) and 75 mg BID demonstrated a significant reduction in the number of gadolinium enhancing T1 (T1 Gd+) lesions measured at weeks 12, 16, 20, and 24, compared with patients receiving a placebo. According to the data, the mean total of T1 Gd+ lesions weeks 12 through 24 was 3.85 (5.44), 4.06 (8.02), 1.69 (4.69), and 1.15 (3.70) in the placebo, evobrutinib, and BID groups respectively. T1 Gd+ lesions per scan were significantly reduced with evobrutinib 75 mg QD and 75 mg BID, but not with 25 mg QD, according to the study.
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