Merck KGaA, a renowned science and technology company, has announced the results of its two Phase III EVOLUTION clinical trials (evolutionRMS 1 and evolutionRMS 2), which investigated the efficacy and safety of evobrutinib, a promising oral medication for relapsing multiple sclerosis (RMS). Unfortunately, the trials did not meet their primary endpoints as the annualized relapse rates (ARR) in patients treated with evobrutinib were equivalent to those treated with the comparator drug, teriflunomide.
Despite the ARR results, the safety and tolerability profile of evobrutinib matched the positive outcomes seen in earlier Phase II trials. Danny Bar-Zohar, the Global Head of R&D and Chief Medical Officer at Merck’s healthcare sector, expressed disappointment but reiterated the company’s dedication to continuing to improve its healthcare offerings through both its current portfolio and new innovations. Comprehensive data analysis from the EVOLUTION trials will be undertaken and shared in the future.
Evobrutinib, designed to modulate B cell responses and macrophage/microglia activation, is part of Merck’s commitment to addressing unmet needs in the treatment of MS, a debilitating neurological disease affecting millions worldwide. The EVOLUTION program was comprehensive, involving a sizable number of patients in studies comparing evobrutinib with teriflunomide over a considerable time frame. The results from this research will inform Merck’s continued efforts in the neurology and immunology therapeutic areas.