Lack Of Efficacy, Not Safety, Dooms Merck KGaA’s BTK Inhibitor

Evobrutinib flunked its Phase III multiple sclerosis program not because of its known toxicity, but because it didn’t work.  

A man shows a thumb down. Gesture of disapproval and rejection. Bad assessment, harsh criticism, failure and defeat. Refusal to pass and cooperation. Bureaucratic obstacles. Contempt and condemnation

Merck KGaA, its investors and sellside analysts alike found themselves casting around for excuses today after the total failure of evobrutinib in its twin pivotal multiple sclerosis trials. The finding is particularly ironic given that most Merck followers were concerned about evobrutinib’s safety, not its efficacy.

Key Takeaways
  • The failure of evobritinib in multiple sclerosis removes a key growth driver for Merck KGaA
  • Three other BTK inhibitors are in very similar Phase III trials, and Sanofi, Roche and Novartis must now fear similar losses
  • Sanofi’s asset, tolebrutinib,

Thus the data clearly came as a shock, and Merck’s stock is trading down by 13%

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