Clinical Trials

Date: 2017-09-12

Type of information: Initiation of the trial

phase: 2b

Announcement: initiation of the trial

Company: Merck KGaA (Germany)

Product: evobrutinib - M2951

Action mechanism:

tyrosine kinase inhibitor/Bruton tyrosine kinase inhibitor . Evobrutinib (M2951) 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 in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
Evobrutinib has been discovered by Merck KGaA.

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

Latest news:

• On September 12, 2017, Merck KGaA announced that it is continuing to advance its Immunology pipeline. Evobrutinib is now in Phase IIb studies across multiple immunological indications: rheumatoid arthritis (RA), multiple sclerosis (MS), and systemic lupus erythematosus (SLE). In RA, Merck KGaA, Darmstadt, Germany, recently initiated a Phase IIb study after results from a small Phase IIa signal-generating study (n=65) met the pre-defined criteria for progressing to a dose finding study. The purpose of this signal study was to characterize the role of evobrutinib in patients with a broad range of disease activity. The study did not reach the statistical criteria across all patients enrolled, however, there was a clear positive outcome in the pre-specified patient population conventionally studied across RA pivotal trials, which is the population to be enrolled in the Phase IIb dose-finding study. Full results of the Phase IIa trial will be presented at a future scientific meeting.