Note: This story was updated May 27, 2020, to note a change in the protocol of the EVOLUTION trials, which are now comparing evobrutinib with Aubagio, rather than Avonex, along with updated NCT numbers.
The study, “Efficacy and Safety of the Bruton’s Tyrosine Kinase Inhibitor (BTKI) Evobrutinib in Relapsing Multiple Sclerosis Over 108 weeks: Open-label Extension to a Phase II Study,” was sponsored by Merck KGaA — known as EMD Serono in the U.S. and Canada — the company developing evobrutinib.
Evobrutinib works by blocking the activity of Bruton’s tyrosine kinase (BTK), a protein that is important for the activation of certain types of immune cells — like B-cells — that drive inflammation that damages the nervous system in MS.
Its efficacy and safety were evaluated in a Phase 2 clinical trial (NCT02975349) that enrolled 267 people with relapsing MS, which includes relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
In the initial trial, which lasted 48 weeks, participants were randomly assigned to one of five groups: three groups were given evobrutinib at different doses (25 mg once daily, 75 mg once daily, or 75 mg twice daily); a fourth was given a placebo; and the fifth was given Tecfidera (dimethyl fumarate), an approved oral therapy by Biogen.
Results from this part of the trial showed that evobrutinib, at 75 mg twice daily (highest dose tested), significantly reduced the annualized relapse rate compared to placebo — 0.11 vs. 0.37 relapses/year — with 79% of participants on this dose group remaining relapse-free after 48 weeks.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?