DARMSTADT, GERMANY-- April 04, 2022 -- DARMSTADT, Germany--(BUSINESS WIRE)-- Merck, a leading science and technology company, today announced 13 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held April 2-7. Data being presented include presentations on investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib, including new 2.5-year efficacy and safety data in patients with relapsing multiple sclerosis (RMS) from a Phase II open-label extension study and a Phase II post-hoc analysis demonstrating that treatment with evobrutinib led to a reduction in slowly expanding lesions (SEL), which may be associated with chronic inflammation in the central nervous system (CNS). Additionally, retrospective real-world efficacy and safety data on MAVENCLAD (cladribine tablets) will be presented, including relapse data compared to other oral disease modifying therapies (DMTs) as well as COVID-19 outcomes.

“Focusing on the needs of people with MS is at the heart of everything we do. This includes innovative research with real-world data to better understand the effectiveness of MAVENCLAD in clinical practice to help inform treatment decisions,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology at Merck. “Additionally, we are working tirelessly on the future of MS treatments with evobrutinib, which targets both acute and potentially also chronic inflammation to prevent disease progression and achieve better outcomes for patients. With new evobrutinib data at AAN, we now have two and a half years of efficacy and safety data in patients with relapsing MS from the largest Phase II BTK inhibitor clinical trial.”

Key evobrutinib data include:

· Safety and efficacy results from the evobrutinib Phase II open-label extension finding no new safety signals and maintained efficacy (annualized relapse rate of 0.12 for patients receiving evobrutinib 75mg twice-daily in the 48-week double-blind period) over 2.5 years in patients with RMS
· Data from a post-hoc analysis in the Phase II trial with evobrutinib demonstrating a reduction in volume of SELs, an in-vivo magnetic resonance imaging (MRI) correlate with chronic active inflammation and axonal loss within the CNS, which may be predictive of subsequent clinical disease progression in MS

Key MAVENCLAD (cladribine tablets) data include:

· Data from the Phase IV CLARIFY-MS and MAGNIFY-MS studies demonstrating MS patients treated with MAVENCLAD who acquired COVID-19 typically experienced mild to moderate disease symptoms/effects with no increased risk of serious outcomes from COVID-19 infection
· Data from the GLIMPSE study*, a longitudinal, retrospective analysis of adult patients identified with RMS from the MSBase Registry, showing MAVENCLAD had lower annualized relapse rates and lower risk of relapse than fingolimod, dimethyl fumarate and teriflunomide in RMS patients

Additional Company activities at AAN 2022:

· Industry Therapeutic Update 1: “Early DMT Switch Considerations in MS and Discussing the Capacity to Mount an Immune Response” chaired by Ann Bass, MD, Medical Director of the comprehensive MS clinic at the Neurology Center of San Antonio (April 2, 7-8:30 pm PDT, Grand Ballroom, Sheraton Grand, Seattle)
· Industry Therapeutic Update 2: “Seeing What’s Unseen in MS” chaired by Jiwon Oh, MD, PhD, Medical Director, BARLO MS Centre, St. Michael’s Hospital, Toronto (April 4, 7-10 pm PDT, Grand Ballroom, Sheraton Grand, Seattle)