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Update on phase III results for evobrutinib in relapsing multiple sclerosis

12 December 2023

  • The EVOLUTION clinical trials examined evobrutinib’s effectiveness in reducing relapse rates in participants with relapsing MS.
  • Results revealed that over a span of up to 156 weeks, evobrutinib did not meet the intended primary endpoint when compared to teriflunomide, an existing oral treatment for relapsing MS.
  • Secondary outcomes of the trial, including the effects of evobrutinib on disability progression, brain volume, and other indicators of damage are yet to be published.

Initial findings from EVOLUTION trials announced

In a recent news release, science and technology company Merck disclosed outcomes from its Phase III EVOLUTION trials evaluating the Bruton’s tyrosine kinase (BTK) inhibitor, evobrutinib, in individuals with relapsing multiple sclerosis (RMS).

The findings revealed that evobrutinib did not meet the primary goal of reducing annualised relapse rates (ARR) when compared to oral teriflunomide, a standard anti-inflammatory treatment for RMS.

About evobrutinib

Evobrutinib, a type of drug known as a BTK inhibitor, is an experimental oral drug being studied as a potential treatment for RMS. It works by targeting specific cells in the brain and immune system.

There are several BTK inhibitors currently in clinical trials for MS. This new class of therapy is generating much interest because BTK inhibitors work differently from current therapies and could potentially reach and treat the brain and spinal cord directly.

The EVOLUTION trials

The trials, known as ‘evolutionRMS 1’ and ‘evolutionRMS ’, demonstrated similar rates of annualised relapse in participants treated with evobrutinib or teriflunomide.

In simpler terms, the frequency of relapses for individuals taking evobrutinib was not significantly different from those taking teriflunomide. Interestingly, the annualised relapse rates observed in individuals treated with teriflunomide were lower in this trial (i.e., teriflunomide proved more effective) than it had been in other recent Phase III studies.

Despite not meeting the primary goal, the safety and tolerability for those on evobrutinib treatment remained consistent with earlier Phase II trial results.

There will now be a comprehensive evaluation of the data from the EVOLUTION trials and collaboration with investigators to present and publish these findings in the future.

Can we conclude that evobrutinib is no more effective than teriflunomide?

Before reaching definitive conclusions, it’s important to wait for the full published data on these results and further data from the EVOLUTION trials, specifically focusing on disability progression, brain volume, and other indicators of damage.

What does this mean for individuals with MS?

The results from these trials unfortunately indicate that while evobrutinib had ambitious goals to address the unmet needs in RMS, it did not demonstrate superiority over a standard treatment in reducing relapse rates.

While these first results are disappointing, we look forward to seeing the effects of evobrutinib on additional outcomes, and the results of other BTK inhibitor trials underway for MS. Research is an ongoing journey. Both positive and negative findings help us understand diseases better, leading to the development of more effective treatments.

The commitment of researchers and trial participants remains crucial in our quest for better MS treatments and solutions for other conditions. Collaborating with industry and research institutions showcases our collective determination to positively impact the lives of those with MS.

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Update on phase III results for evobrutinib in relapsing multiple sclerosis