Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies

Merck, a leading science and technology company, today announced that its two Phase III EVOLUTION clinical trials (evolutionRMS 1 and evolutionRMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (0.11 vs. 0.11 in evolutionRMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolutionRMS 2, p=NS in both trials). Of note, teriflunomide ARR values were lower than reported in other recent Phase III studies. The overall safety and tolerability profile was consistent with results from the previously reported Phase II trial. The company will complete a full evaluation of the data from the EVOLUTION clinical trials and will work with investigators on the future presentation and publication of the results.

“With evobrutinib, our aim was to address the significant unmet need of smoldering MS in addition to strong relapse control for people living with this condition,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. “While we are very disappointed with the results, we continue to advance our strategy in healthcare with a focus on progressing our marketed portfolio and internal pipeline, complemented by external innovation, with the aim of bringing more medicines to patients, faster. I would like to sincerely thank all patients participating in the trials, their caregivers and our network of dedicated clinical investigators.”