Merck completes enrolment of Evobrutinib Phase III Trials ahead of ECTRIMS 2021

Key MAVENCLAD (cladribine tablets) data include:

• Updated post-approval safety of MAVENCLAD demonstrating consistency of real-world experience with the profile reported in the Phase III and ongoing Phase IV trials, and providing evidence that patients receiving MAVENCLAD do not appear at increased risk of severe COVID-19 outcomes
• In an independent open label study, patients treated with MAVENCLAD were found to increase antibody immunoglobulin G (IgG) titer levels similar to healthy controls after a complete course of an mRNA COVID-19 vaccine
• A new interim analysis from the Phase IV CLARIFY-MS study demonstrating that patients living with RMS reported an improvement in physical and mental health at one year of MAVENCLAD treatment
• Real-world MAVENCLAD data from the MSBase Registry demonstrating adherence to MAVENCLAD and an annualised relapse rate similar to clinical trial data
• Late-breaking data including:
  • Long-term Efficacy for Patients Receiving Cladribine Tablets in CLARITY/CLARITY Extension: Primary Results from 9–15 Years of Follow-up in the CLASSIC-MS Study
  • Cladribine tablets after treatment with natalizumab (CLADRINA) trial – Interim analyses

Key evobrutinib data include:

• Data from a post-hoc analysis in the Phase II trial with evobrutinib demonstrated a reduction in volume of slowly expanding lesions (SELs), an in-vivo magnetic resonance imaging (MRI) correlate of chronic active inflammation and axonal loss within the central nervous system (CNS), which may be predictive of subsequent clinical disease progression in MS
• Results from the same trial showed that increased levels of blood neurofilament light chain (NfL), a marker of neuronal damage, at baseline were predictive of increased relapse and MRI lesion activity in the study and evobrutinib significantly reduced MRI and relapse outcomes
• Safety profile characterisation of evobrutinib in over 1000 patients from Phase II clinical trials in MS, rheumatoid arthritis and systemic lupus erythematosus demonstrating that overall evobrutinib treatment (all doses) was generally well tolerated across indications and elevations in liver enzymes were asymptomatic and reversible

Additional Company activities at ECTRIMS 2021:

• Satellite symposium: "Supporting patient needs in MS every step of the way" co-chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry and Prof. Barbara Kornek, Department of Neurology at the University of Vienna.
• Medical education symposium "MS innovation in practice: the continuing search for novel therapeutic targets" co-chaired by Prof. Patrick Vermersch, Vice President for research in biology and health at the University of Lille, and Dr. Xavier Montalban, Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.