Evobrutinib heads to phase III in multiple sclerosis

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Undeterred by the cautious tone of last week’s NEJM paper on evobrutinib’s phase II data in multiple sclerosis Merck KGaA is to press ahead with a pivotal trial of this BTK inhibitor. Luciano Rossetti, Merck’s head of R&D, told Vantage that the group had agreed with regulators on a single dose to take forward; presumably this is 75mg once daily, though he would not confirm this. The paper had raised questions about statistical significance, but Mr Rossetti insisted that this was down to the NEJM applying to phase II “the same statistical criteria that you would use in a larger phase III” study. In fact, he argued, using rigorous p values in initial trials like evobrutinib’s was “extremely faulty”. One consideration in picking a phase III dose is liver enzyme elevations seen in phase II, which Mr Rossetti accepted were important and needed to be monitored. It is still not clear why so few other BTK players are looking at multiple sclerosis; Mr Rossetti noted that the shift to highly selective inhibitors like evobrutinib was recent, adding: “I would not be surprised if after our success ... there was a lot more interest.”

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