The clinical outcome of BTK inhibitors in the treatment of multiple sclerosis is gratifying

The clinical outcome of BTK inhibitors in the treatment of multiple sclerosis is gratifying

March 09, 2018 Source: WuXi PharmaTech

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Recently, Merck KGaA, based in Darmstadt, Germany, published positive results from a Phase 2b clinical study evaluating evobrutinib in patients with relapsing multiple sclerosis. Effect and safety. The study reached the primary endpoint, demonstrating a clinically significant reduction in T1 lesions measured by magnetic resonance imaging (MRI) at various time points in patients receiving evobrutinib compared with patients receiving placebo.

Multiple sclerosis (MS) is an autoimmune disease that occurs in the central nervous system and is attacked by the autoimmune system. Myelin is a lipid that encapsulates and protects nerve fibers in the brain and spinal cord. Inflammation and tissue damage caused by MS can destroy the normal function of the brain, optic nerve and spinal cord. The main age of onset of MS is 20 to 40 years old, which is the cause of disability of young and middle-aged people after trauma. About 2.5 million people worldwide are affected by MS, about 400,000 in the United States, and there are tens of thousands of new MS cases each year. At present, there is no cure for MS, and the main goal is to control the progress of the disease. Therefore, there is still an unmet medical need for the disease of MS.

â–²Image source: 123RF

Evobrutinib (M2951) is a new drug and is currently undergoing clinical evaluation in patients with MS, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is a highly selective oral inhibitor of Bruton's Tyrosine Kinase (BTK). BTK is a tyrosine kinase that is important for the development and function of various immune cells, including B lymphocytes and macrophages. Researchers believe that by inhibiting BTK, it is possible to inhibit the production of autoantibodies. Preclinical studies have shown that inhibition of BTK may have therapeutic effects on certain autoimmune diseases. This trial of Merck in Germany is also the first proof-of-concept test to apply BTK inhibitors in MS patients. Evobrutinib is designed to inhibit the response of primary B cells in MS patients, such as proliferation and release of antibodies/cytokines, without directly affecting T cell function.

The results of this release were obtained from a randomized, double-blind, placebo-controlled Phase 2b clinical study using a parallel open-label active control group (Tecfidera) to evaluate the efficacy, safety, and efficacy of evobrutinib in MS patients. Tolerance, pharmacokinetics and biological activity. Tecfidera (dimethyl fumarate, dimethyl fumarate) is an oral drug approved by the US FDA for the treatment of MS in 2013.

The trial enrolled 267 patients who were randomized into 3 groups and received evobrutinib, placebo or Tecfidera for 24 weeks. After 24 weeks, patients in the placebo group were also given M2951. The primary goal of the trial was to change the condition of patients receiving evobrutinib compared to the placebo group at weeks 12, 16, 20 and 24. Secondary goals included annual recurrence rate, rate of recurrence-free patients, changes in baseline with extended Disability Status Scale (EDSS), and number of patients with adverse events.

The data showed that at 12, 16, 20, and 24 weeks, patients taking evobrutinib had a clinically significant reduction in sputum-enhanced T1 injury compared with placebo when MRI was performed.

“We are encouraged by the early positive results of these evobrutinib treatments for patients with relapsed MS,” said Dr. Luciano Rossetti, Head of Global R&D at Biomedical Business in Merck, Germany. “This study will continue as a clinical development strategy for evobrutinib for MS. Provide further information."

We congratulate Merck of Germany and hope that evobrutinib will bring the means of controlling the disease to MS patients as soon as possible.

Reference materials:

[1] Merck KGaA, Darmstadt, Germany, Announces Positive Phase IIB Results for Evobrutinib in Relapsing Multiple Sclerosis

[2] A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis

[3] Evobrutinib Positive Phase IIb Results - US

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