Publication date: Sep 10, 2019
DARMSTADT, Germany–(Business Wire)–Merck, a leading science and technology company, today announced the initiation of two global pivotal Phase III trials ( EVOLUTION RMS 1 and 2 ) studying the efficacy and safety of evobrutinib, an oral, highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS).
-Evobrutinib is a potential innovation for people living with MS, as it may offer a novel dual mechanism of action that is thought to impact myeloid cells in addition to B-cells and thus could address MS pathobiology in a fundamentally new way,” said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck.
Evobrutinib is entering Phase III trials following the results of the Phase II clinical trial, which met its primary endpoint over 24 weeks of treatment, where the total cumulative number of T1 gadolinium-enhancing (Gd+) lesions was reduced with evobrutinib compared with placebo.
As part of Merck’s commitment to patient-focused drug development, the company collaborated with the Accelerated Cure Project (ACP) for Multiple Sclerosis and its iConquerMS people-powered research network to capture and integrate the perspectives of people affected by MS into the design and implementation of the clinical trials.
-Even with the most effective therapies for RMS, more than 50% of patients experience clinical or subclinical disease activity, therefore a need still exists for novel oral therapies that address MS pathobiology differently,” noted Dr. Xavier Montalban, Professor of Medicine and Department Division Director, Neurology, at the University of Toronto, Director of the MS Centre at St. Michael’s Hospital, Canada, Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d’Hebron University Hospital, Barcelona, Spain and principal investigator for the EVOLUTION RMS 2 trial.
About Evobrutinib 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).
The global Phase III clinical development programme evaluating evobrutinib in MS includes two pivotal studies, EVOLUTION RMS 1 and 2.
The company’s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.
The company’s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).