Merck KGaA ( OTCPK:MKGAF ) ( OTCPK:MKKGY ) said its drug evobrutinib showed sustained clinical benefit in people with relapsing multiple sclerosis (MS) through more than three and half years.
Merck KGaA' Healthcare business EMD Serono reported data from the open-label extension (OLE) part of a phase 2 trial.
The company said annualized relapse rates (ARR) remained low and Expanded Disability Status Scale (EDSS) scores — a measure of checking the level of disability in patients with MS — were stable.
Patients in the initial 75mg twice-daily group, maintained a low ARR of 0.13 throughout the OLE. In addition, switching from 75mg once-daily to 75mg twice-daily in the OLE reduced ARR from 0.19 to 0.09, the company added.
Overall, average EDSS scores, and MRI lesion activity remained low and stable throughout the entire study, EMD Serono noted.
In addition, the company said that patients experienced sustained and ongoing reductions in blood neurofilament light chain (NfL) levels — a biomarker which may predict future brain volume loss and disease progression — compared to the double-blind period (DBP) and OLE baseline values.
The German company presented the data at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
EMD also presented post hoc analysis of vaccinated patients (n=24) in the phase 2 OLE study, showing 96% of people with RMS treated with evobrutinib (75mg twice daily) were able to mount an antibody response following two doses of an mRNA COVID-19 vaccine, similar to untreated RMS patients and healthy people.
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Merck KGaA multiple sclerosis drug evobrutinib shows benefit across 3 years in trial