New Late-Breaking Data at EAN Indicate Evobrutinib is the First BTK Inhibitor to Report Efficacy and Safety in MS Over 108 Weeks

ROCKLAND, Mass., May 23, 2020 /PRNewswire/ --A EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced data on the long-term efficacy and safety profile of evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS). The results from the Phase II open-label extension (OLE) study will be presented as a late-breaker at the European Academy of Neurology (EAN) 2020 Virtual Congress. "These data demonstrate evobrutinib has a sustained and high impact on annualized relapse rate over 108 weeks," said Luciano Rossetti, Head of Global Research & Development for EMD Serono. "Greatest efficacy was clearly associated with BTK occupancy, and this further validates our choice of dose for the Phase III program. We are also encouraged by evobrutinib's breadth of consistent safety data, including no increase of serious infections in more than 1,200 patients up to two years." Annual relapse rate (ARR) results in the double-blind phase of the study were maintained over the open-label extension, with patients receiving evobrutinib 75mg BID (twice a day) in the double-blind phase showing an ARR of 0.11 (95% CI 0.04a??0.25) at week 48, and of 0.12 (0.06a??0.22) for the 108-week period.The data from the Phase II study continues to demonstrate that BID dosing can achieve higher efficacy than QD dosing on clinical outcomes, as demonstrated by reduced ARR. Modelling data show that greater than 95% BTK occupancy at trough is necessary in nearly all patients to achieve highest efficacy and this can be best achieved with BID dosing.Data previously published in the New England Journal of Medicine reported the findings of the Phase II study where at 24 weeks, evobrutinib significantly reduced the cumulative number of T1 Gd-enhancing lesions compared to placebo, meeting its primary endpoint. At week 48, all patients could enter the OLE which assessed the long-term efficacy and safety of evobrutinib.A 
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