German Merck Suffers Setback -- In Potential MS Candidate, Evobrutinib... So It Goes.

Thus Sanofi’s Aubagio^® (the current standard of care, in MS) remains the top of the heap. Many pharmacos were looking at BTK inhibitors as the next generation -- for MS therapy. It is fair to say that the Germans' misses have chilled the entire space. But that -- after all -- is what science is about: trial and error; and then a redirecting of efforts based on the shared learnings.

Are Biogen, Novartis and Roche each re-evaluating their MS / BTK development programs? We shall soon see. In the mean time, here's some of Fierce's fine reporting on it all:

. . .It’s been a quick fall from grace for evobrutinib. Only months ago, Merck KGaA was outlining hopes for a major commercialization push for the BTK inhibitor -- and now the German pharma has dropped the drug completely.

Merck told Fierce Biotech that the decision was made in response to the failure of evobrutinib to beat Sanofi’s Aubagio in two phase 3 multiple sclerosis (MS) clinical trials in December 2023. With Merck having pinned blockbuster hopes on the drug, the pair of failures sent shockwaves through the BTK inhibitor space at the time. . . .

Up to the phase 3 readouts, the company had maintained sky-high hopes for the drug. As recently as November, Merck had outlined plans to support evobrutinib with a major commercialization push, telling investors that launch preparations would drive up costs starting in the fourth quarter and mulling whether to use a voucher to accelerate the FDA review.

On a call with analysts to discuss the earnings results, Merck CEO Belén Garijo admitted the BTK inhibitor’s failure “was no doubt a disappointment. . . .”

Onward, smiling into the Sunday sunshine -- for a brisk ride by the lake. . . .

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