Evobrutinib, CNS-Penetrant BTKi, Has Shown Sustained Clinical Benefit Up to Five Years in People with RMS

Data from the ongoing Phase II open-label extension (OLE) study of evobrutinib show sustained clinical efficacy and a safety profile that remains consistent with that previously reported over five years of therapy - the longest follow-up of any Bruton’s tyrosine kinase inhibitor (BTKi) in multiple sclerosis (MS) studies Additional Phase II OLE data show significant and clinically meaningful improvements on mental health and quality of life measures in study participants with relapsing multiple sclerosis (RMS) Evobrutinib is an investigational highly selective, oral, central nervous system (CNS)-penetrant BTKi with the potential to transform the RMS treatment landscape by targeting smouldering MS on top of peripheral nervous system inflammation to address both relapses and disability progression independent of relapses EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new five-year data from the open-label extension (OLE) of the Phase II clinical trial, which demonstrated that people with relapsing multiple sclerosis (RMS) treated with investigational BTK inhibitor (BTKi) evobrutinib continued to have low annualized relapse rates (ARR), with a high proportion of patients showing no evidence of clinical worsening. Additional patient-reported data from the study showed statistically significant and clinically meaningful improvements in mental health and vitality, which is closely related to fatigue. These data, presented at the 9th Joint ECTRIMS-ACTRIMS meeting, may indicate the long-term positive benefits of evobrutinib for people with RMS. “The data presented at ECTRIMS-ACTRIMS provide further insights into the sustained safety and efficacy profile of evobrutinib and showcase its potential to reduce fatigue in people with RMS, a common, often debilitating symptom that can impact quality of life,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology at Merck KGaA, Darmstadt, Germany. “Evobrutinib also has the potential to directly address smouldering inflammation in RMS, a previously underestimated contributor to disease progression that is insufficiently addressed with existing treatments. Together, these data continue to reinforce our confidence in evobrutinib in addressing the major unmet need seen with current RMS treatment options.” Data from the ongoing Phase II OLE trial showed sustained clinical efficacy and safety over five years of treatment with evobrutinib, with no evidence of clinical worsening (defined as being free from relapses and disability progression) in 87.1% of patients in year five. During the OLE, patients were switched from evobrutinib 75 mg once-daily to 75 mg twice-daily resulting in additional ARR reduction. The overall pooled ARR remained low at 0.11. No new safety signals were observed in the OLE and evobrutinib continued to show consistent tolerability up to five years of treatment. Overall, treatment emergent adverse events (TEAEs) were mild/moderate in the OLE, with 3.3% (n=7) of patients with RMS experiencing a serious TEAE. Collectively, the findings may indicate sustained benefit of long-term twice-daily dosing, and the safety profile remains consistent with that previously reported. Additional data from the double-blind period of the Phase II trial demonstrated patients treated with evobrutinib 75 mg twice-daily showed significant and clinically meaningful improvements of mental health and vitality up to 48 weeks vs. placebo and evobrutinib 25 mg once-daily. Improvements were measured by the 36-Item Short Form Survey (SF-36). As part of the study, SF-36 vitality scores were converted to the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue T-scores. Overall, the treatment benefit on PROMIS Fatigue T-scores of evobrutinib up to week 48 in the double-blind period for those taking 75 mg twice-daily suggests evobrutinib may mitigate fatigue, an issue that can greatly impact the quality of life for those living with RMS.

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