Positive Phase II Data Further Highlights Clinical Proof of Concept for Evobrutinib, First Oral Bruton's Tyrosine Kinase (BTK) Inhibitor to Report Positive Phase II Clinical Results in MS

ROCKLAND, Mass., May 10, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new 48-week results of the double-blind, randomized, placebo-controlled, Phase II study of evobrutinib in patients with relapsing multiple sclerosis (RMS). The results have been presented at the American Academy of Neurology (AAN) 2019 Annual Meeting in Philadelphia, PA with simultaneous publication in the New England Journal of Medicine (NEJM). Evobrutinib is the first oral, highly selective Bruton's tyrosine kinase (BTK) inhibitor to show clinical proof of concept in RMS.

Previously reported data showed that the study had met its primary endpoint over 24 weeks of treatment, where the total cumulative number of T1 gadolinium-enhancing lesions was reduced with evobrutinib compared with placebo. With evobrutinib 75 mg QD (once a day) and 75 mg BID (twice a day), rapid reductions in number of T1 Gd+ lesions were observed by week 12 of treatment. New data showed that the effect on T1 gadolinium-enhancing lesions reduction seen at week 12 was maintained through 48 weeks with evobrutinib 75 mg QD and 75 mg BID.

"These positive Phase II evobrutinib data are a great example of the strength of our pipeline and commitment to developing new, innovative treatments in multiple sclerosis," said Luciano Rossetti, Head of Global Research & Development at EMD Serono. "As a leader in autoimmune diseases and MS we are proud of this in-house discovery at EMD Serono. We look forward to continuing to investigate the potential of evobrutinib as we continue to address unmet patient needs in MS care."

With evobrutinib 75 mg BID, annualized relapse rate (ARR) (confidence interval) was 0.11 (0.04-0.25) with 79 percent of patients remaining relapse free over 48 weeks of treatment. For reference, at 24 weeks, ARR for evobrutinib 75 mg BID was 0.08 (0.01-0.30) and 0.37 (0.17-0.70) for placebo.

No treatment associated infections, infestations, or lymphopenia were observed and no new safety signals were identified over 52 weeks. The most common treatment-related TEAEs (>10%) included nasopharyngitis and increased ALT. The percentage of shifts from baseline to Grade 2 or greater in ALT were 5.7%, 3.8%, and 13% in the evobrutinib 25mg QD, 75mg QD and 75mg BID groups, respectively. The corresponding shifts in ALT in the placebo group over 24 weeks was 7.5%. All events had an onset within 24 weeks of treatment initiation and were reversible on treatment discontinuation with no clinical consequences within the 52-week study period. During the course of the study, 85 percent of patients (227 out of 267) completed 52 weeks of treatment.

"Building on our initial analysis at 24 weeks, these new data further demonstrate the potential role of evobrutinib in relapsing multiple sclerosis, subject to further clinical investigation" said Dr. Xavier Montalban, Professor of Medicine and Department Division Director, Neurology, at the University of Toronto and Director of the MS Centre at St. Michael's Hospital, Canada, and Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain. "Evobrutinib is the first Bruton's tyrosine kinase inhibitor to demonstrate clinical proof of concept in multiple sclerosis. We are pleased that these 48-week data further support our continued clinical development of evobrutinib and investigation into its efficacy for patients with MS."

These 48-week results are a new analysis following the initial 24-week presentation of the data at the 34^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany, on October 12, 2018.

EMD Serono presented a total of 20 abstracts (18 posters and two platform presentations) during AAN 2019. For further information on the evobrutinib 48-week abstract please see here:

• Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Patients with Relapsing Multiple Sclerosis over 48 Weeks: a Randomized, Placebo-Controlled, Phase 2 Study – presented at 1:33 PM ET on Friday, May 10 during the S56: MS Trials and Treatment session.

The presentation of these data read-outs showcases the breadth of EMD Serono's multiple sclerosis (MS) portfolio and further underscores its commitment to the advancement of MS treatment.

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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). 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. Selectivity has been assessed in vitro. 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 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

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