Merck KGaA (Merck) has reported that its two Phase III EVOLUTION clinical trials of evobrutinib in relapsing multiple sclerosis (RMS) patients failed to meet primary endpoints.
Dubbed evolutionRMS 1 and evolutionRMS 2, the parallel-group, randomised, double-dummy, double-blind, active-controlled trials analysed the safety and efficacy of oral evobrutinib compared to oral teriflunomide in RMS patients.
The trials enrolled patients with relapsing-remitting MS or secondary progressive MS with relapses.
These subjects were randomised into a 1:1 ratio to receive either 45mg evobrutinib twice-a-day, plus an oral placebo once daily, or 14mg teriflunomide once a day, with an oral placebo twice daily for up to 156 weeks.
The trials did not meet the primary endpoint of reducing annualised relapse rates (ARR) in RMS patients.
In these trials, treatment with teriflunomide resulted in ARR values that were less than those reported in various other Phase III studies.
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Evobrutinib’s overall safety and tolerability profile in the EVOLUTION trials was found to be in line with those seen in the Phase II trial.
An oral, central nervous system (CNS)-penetrating Bruton’s tyrosine kinase (BTK) inhibitor, evobrutinib can alter B cell responses and modulate the activation of macrophage/microglia.
Merck’s chief medical officer Danny Bar-Zohar 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.”
The latest development comes after Merck signed an agreement to commercialise products that include or contain Abbisko Therapeutics’ pimicotinib (ABSK021) for all indications.
Under the deal, Merck will receive an exclusive licence to market the products in licensed territories, including the Chinese mainland, Hong Kong, Macau, and Taiwan.