EMD Serono to Present Multiple Sclerosis Data on Cladribine Tablets and Evobrutinib at ACTRIMS 2019

ROCKLAND, Mass., Feb. 28, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, will present data at the fourth annual ACTRIMS (Americas Committee for Treatment and Research in Multiple Sclerosis) Forum taking place February 28-March 2 in Dallas, TX. These data include efficacy and safety results for cladribine tablets and evobrutinib, investigational agents for relapsing MS. 

Cladribine tablets has been studied as a short-course (a maximum of 20 days of treatment over two years) oral therapy. It is thought to preferentially target lymphocytes, which may be integral to the pathological process of RMS. Data presented on cladribine tablets at ACTRIMS will include:

• Durability of NEDA (no evidence of disease activity) status in patients with RMS;
• An updated safety analysis, including up to 10 years of follow-up data in some patients;
• An exploratory analysis of the efficacy in patients with relapsing MS stratified according to age;
• An analysis of severity and frequency of relapses in patients with relapsing MS.

"The efficacy of cladribine tablets was evaluated in the CLARITY, CLARITY EXT, and ORACLE-MS trials that included patients with RMS," said Stuart Cook, MD, Professor Emeritus at Rutgers, New Jersey Medical School. "Building on existing clinical evidence, I am pleased to present an updated safety analysis on cladribine tablets at ACTRIMS, which includes up to 10 years of follow-up data in some patients."

The integrated analysis of patients from the clinical trial program also includes two additional years of data from the long-term PREMIERE Registry.¹

Data on evobrutinib will include an oral presentation of the primary safety and efficacy analysis from a Phase II study in patients with relapsing MS and on prevention of inflammatory macrophage differentiation. Evobrutinib is a highly-specific, oral Bruton's Tyrosine Kinase (BTK) inhibitor and the first BTK inhibitor to show clinical proof-of-concept in RMS.

"We are proud to participate in the important scientific exchange at ACTRIMS as it aligns with our commitment to advancing MS science to address patient needs with our research programs and investigational MS treatments," said John Walsh, M.D., Vice President, Neurology and Immunology, US Medical Affairs, EMD Serono.

The EMD Serono Medical Affairs Exhibit Booth at ACTRIMS 2019 will offer participants the chance to make a charitable donation to Can Do MS by participating in the construction of a neuron scaffolding. The goal is to reach a total donation of $10,000 by conference end.

Below are data abstracts from our investigational products that were accepted as posters for presentation at ACTRIMS.

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About Cladribine Tablets
Cladribine tablets (marketed as MAVENCLAD^® outside the U.S.) is an investigational oral therapy studied as a short 8-10 day per year treatment regimen that is thought to preferentially target lymphocytes which may be integral to the pathological process of relapsing MS (RMS). Cladribine tablets is currently undergoing FDA review and is not approved for the treatment for any use in the United States. Cladribine tablets has been approved in 50 countries, including the European Union (EU), Canada, and Australia, for various relapsing MS indications.

The clinical development program for cladribine tablets includes:

• The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.
• The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
• The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
• The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
• PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators.  Adverse Events reported in other clinical studies were similar.² 

About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for 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. As BTK is not expressed in T cells, evobrutinib does not directly affect 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.

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

EMD Serono, Inc. and Multiple Sclerosis
For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.

About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada – is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,300 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com

References
1. Cook S., Giovanonni G., et al. Updated Safety Analysis of Cladribine Tablets in the Treatment of Patients with Multiple Sclerosis. Presentation at ACTRIMS 2019.
2. Cook S, Vermersch P, et al. Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study. Multiple Sclerosis Journal 17(5) 578–593; 2010

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