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In wake of Eli Lilly setback, Merck KGaA’s leading BTK drug for autoimmune disease clears PhIIb hurdle

What kind of future awaits Bruton’s tyrosine kinase drugs in autoimmune conditions?

A familiar player in hematology, which attracted the first big round of investment for BTK drugs like ibrutinib that can hit back at abnormal B cells, researchers have been exploring uncharted avenues of drug development for autoimmune diseases. And the potential leader in the field, Merck KGaA’s evobrutinib, just cleared a big hurdle in the clinic that just might lay the foundation for a pivotal effort around multiple sclerosis.

We just don’t know for sure exactly what happened.

Luciano Rossetti, Merck KGaA

Merck KGaA put out one of the least detailed statements you’ll ever see for a Phase IIb study, saying the drug did hit the primary endpoint. But even though their top execs are staying mum about exactly what they found, they’re also clearly proud about what they have accomplished so far.

“It’s our own drug, one of our major achievements,” company R&D chief Luciano Rossetti tells me.

This is a first for the field, he adds, with clear data to prove that a Bruton’s tyrosine kinase inhibitor can work in treating MS. The drug clearly hit on two of three doses with statistically significant data, he says, demonstrated by tracking lesions periodically up to week 24 for the primary endpoint.

Just how big an achievement it is, though, we don’t know. The company is keeping the data under tight wraps for now, and there’s no automatic decision in place to move on into a big, pricey pivotal program.

BTK inhibitors for autoimmune conditions have attracted some deep interest among the top players in the field. Sanofi struck an $805 million deal — with a $40 million upfront — to line up a pact with Principia on a preclinical program for PRN2246 last fall. But Eli Lilly just wrote off a mid-stage BTK drug for rheumatoid arthritis that it in-licensed from Hanmi. Celgene lost interest in CC-292 after their BTK drug performed poorly in Phase IIa. Bristol-Myers is pushing ahead with BMS-986142, meanwhile, while AbbVie has ABBV-105 in early-stage development.

In addition to the drug arm, Rossetti says, researchers also tracked a placebo group as well as a Tecfidera arm. And in a competitive field like this, there are plenty of considerations that have to be reviewed about the market worthiness of a drug like this.

“We wish to see the complete data information,” says the R&D chief. And even though the primary endpoint was set for 24 weeks, they’re also gathering 48 week data as well. In addition, the drug is also in trials for lupus and rheumatoid arthritis, with readouts expected later for the other two indications.


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