Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show.
Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary Analysis of a Randomized, Placebo-Controlled, Phase II study of the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib (M2951) in Patients with Relapsing Multiple Sclerosis,” at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, that ran from Feb. 28 to March 2, 2019, in Dallas, Texas.
Evobrutinib (M2951), developed by Merck KGaA (known as EMD Serono in the U.S. and Canada) is a highly specific, oral inhibitor of Bruton’s tyrosine kinase (BTK), which is vital for the development and functioning of several immune cells. These include antibody-producing B-cells and macrophages.
By inhibiting BTK, evobrutinib suppresses autoantibody-producing cells, a common feature in autoimmune diseases like MS.
According to Montalban, preclinical studies in animal models of MS suggested that evobrutinib could reduce inflammation in the central nervous system, and ameliorate disease severity.
The ongoing Phase 2b trial (NCT02975349), sponsored by the EMD Serono Research & Development Institute, has enrolled 267 patients, ages 18 to 65, with active relapsing MS — either relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with relapses. The aim is to assess the safety and efficacy of evobrutinib compared to a placebo.
Those in the evobrutinib group are receiving one of three doses — low (25 mg once daily), middle (75 mg once daily), or high (75 mg twice a day) — for 48 weeks (11 months). Patients in the placebo group receive a placebo for 24 weeks, followed by low-dose evobrutinib for another 24 weeks.
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