Argentina – Phase III Clinical Trial of BTK inhibitor.

Investigational evobrutinib is the first Bruton’s tyrosine kinase (BTK) inhibitor to complete Phase III clinical trial enrolment in relapsing multiple sclerosis.
Phase III Clinical Trial of BTK inhibitor in Argentina.

Phase III Clinical Trial of BTK inhibitor.

Merck, a leading science and technology company, today announced enrollment has been completed in the Phase III EVOLUTION RMS clinical trial program, which is evaluating the efficacy and safety of investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib in patients with relapsing multiple sclerosis (RMS). This milestone comes just ahead of the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually from 13-15 October 2021, where 39 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented. Data will include two oral presentations and a late-breaking ePoster on evobrutinib as well as late-breaking ePosters on Mavenclad (cladribine tablets), including new interim data on patient-reported improvements in quality of life (QoL) and new independent data on Mavenclad patients who have received a complete course of an mRNA COVID-19 vaccine.

“The breadth of our data at ECTRIMS, paired with the rapid enrollment in our evobrutinib Phase III EVOLUTION RMS clinical trial program, further exemplifies a commitment to continue breaking boundaries in the science of MS,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck. “By generating new data on Mavenclad to demonstrate the positive real-life impact it can have for people with RMS, and also on progressing evobrutinib with its dual mode of action targeting both B-cells and innate immune cells in the central nervous system and periphery, we are hoping to address the needs of people with RMS now and in the future.”

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 annualized 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 characterization 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.
Phase III Clinical Trial of BTK inhibitor in Argentina.

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