Merck Initiates Pivotal Phase III Programme for Investigational Evobrutinib in Relapsing Multiple Sclerosis

Merck Initiates Pivotal Phase III Programme for Investigational Evobrutinib in Relapsing Multiple Sclerosis

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).

Concepts Keywords
Alanine Aminotransferase Multiple sclerosis research
ALT Magnetic resonance imaging
Aminotransferase Drug development
Antibody Interferon beta-1a
Arthritis Serono
Aspartate Multiple sclerosis
AST Branches of biology
Autoantibody Medicine
Autoimmune Diseases Merck
B Cells Medical specialties
Barcelona Oral therapies
Blurred Vision Autoimmune diseases
BTK Vision numbness
Business Wire Nasopharyngitis
Canada Diseases
Catalonia ACP Multiple Sclerosis
Central Nervous System Healthcare materials
Chronic Diseases Magnetic resonance imaging
Clinical Trial Parallel
Clinical Trials Healthcare
Cytokine MRI
DARMSTADT Bruton’s tyrosine kinase
Double Blind
Drug Development
EMD
Entrepreneurship
Gadolinium
Germany
Healthcare
Hebron
Immunology
Inhibitor
Intelligence
Interferon Beta 1a
Intramuscularly
Lipase
Lymphocytes
Macrophages
Magnetic Resonance Imaging
Mail
Merck
Molecule
Montalban
MRI
Multiple Sclerosis
Myeloid
Nasopharyngitis
Neurological
Neurology
Numbness
Osteoarthritis
Pathogenic
Patient Reported Outcomes
Pipeline
Placebo
Primary Endpoint
Principal Investigator
Register
Relapse
Rheumatoid Arthritis
Spain
Systemic Lupus Erythematosus
Toronto
Tyrosine
Tyrosine Kinase
United Canada

Semantics

Type Source Name
gene UNIPROT MET
drug DRUGBANK Gadolinium
gene UNIPROT CYREN
gene UNIPROT BID
gene UNIPROT PTPN5
disease MESH community
drug DRUGBANK Methionine
disease MESH relapse
gene UNIPROT SLTM
disease MESH Development
gene UNIPROT IMPACT
gene UNIPROT BTK
gene UNIPROT SLC17A5
drug DRUGBANK L-Alanine
disease DOID nasopharyngitis
drug DRUGBANK L-Tyrosine
drug DRUGBANK Nonoxynol-9
gene UNIPROT WIPF2
disease DOID arthritis
disease MESH osteoarthritis
disease DOID osteoarthritis
disease MESH arthritis
disease MESH numbness
disease MESH chronic diseases
gene UNIPROT NDUFAB1
gene UNIPROT PROS1
disease MESH rheumatoid arthritis
disease DOID rheumatoid arthritis
pathway BSID Rheumatoid arthritis
pathway BSID Systemic lupus erythematosus
disease DOID systemic lupus erythematosus
disease MESH systemic lupus erythematosus
disease MESH nasopharyngitis
disease DOID Multiple Sclerosis
disease MESH Multiple Sclerosis
gene UNIPROT EMD
drug DRUGBANK Coenzyme M
gene UNIPROT NFKBIZ
disease MESH autoimmune diseases
pathway BSID Release
drug DRUGBANK Interferon beta-1a

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