Merck’s relapsing multiple sclerosis trial put on FDA partial clinical hold over liver injuries
Merck has announced that its clinical phase 3 study EVOLUTION has been put on partial clinical hold by the US Food and Drug Administration (FDA) over liver injuries found in enrolled patients.
EVOLUTION is a phase 3 clinical trial studying its investigational BTK inhibitor evobrutinib in relapsing multiple sclerosis (RMS). BTK’s target and deactivate the Bruton’s tyrosine kinase protein, which can help in RMS to lower levels of the autoantibodies that attack the protective lining around nerves, aiding in better disease outcomes.
The partial clinical hold disallows the initiation of new patients and patients with less than 70 days exposure to study medication in the US. The FDA decision was based on two cases where a patient’s laboratory values indicated drug-induced liver injury. However, it was reported that both patients were asymptomatic, did not require medical intervention and that their liver enzymes normalised after discontinuation of study medication.
Danny Bar-Zohar, global head of R&D and CMO at Merck, told BioSpace: “The partial hold is a challenge, but we believe that with a good dialogue with experts as well as with [the] FDA we will be able to address it. As always, efficacy is key. The phase 2 data, as well as extension and biomarkers, make us confident in the benefit risk ratio for evobrutinib, and we await our phase 3 data readout to make a compelling case for its therapeutic benefit for patients with RMS.”
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