Shares of Merck KgaA (MKGAY.PK) were losing more than 14 percent in the early morning trading in Germany after the science and technology major said its two Phase III EVOLUTION clinical trials of evobrutinib in Relapsing Multiple Sclerosis or RMS did not meet their primary endpoints.
The company said its evolutionRMS 1 and evolutionRMS 2 trials investigating the efficacy and safety of evobrutinib did not meet its primary endpoint of annualized relapse rate or ARR for up to 156 weeks compared to oral teriflunomide in both studies.
Of note, teriflunomide ARR values were lower than reported in other recent Phase III studies. The company said overall safety and tolerability profile was consistent with results from the previously reported Phase II trial.
Merck plans to 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.
Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck, said, "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. 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."
In Germany, Merck KGaA shares were trading at 139.25 euros, down 14.02 percent.
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