Merck KGaA, Darmstadt, Germany announced positive results from its Phase IIb study of evobrutinib (Bruton's Tyrosine Kinase Inhibitor - BTK) in relapsing multiple sclerosis (MS). The study has met its primary endpoint, demonstrating that evobrutinib resulted in a clinically meaningful reduction of gadolinium enhancing T1 lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo.
"We are encouraged by these early positive results of evobrutinib in relapsing MS," said Luciano Rossetti, Head of Global Research & 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."
Evobrutinib, discovered by Merck KGaA, Darmstadt, Germany, is also in Phase IIb studies in rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is an oral, highly selective inhibitor of Bruton's Tyrosine Kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.