Merck KGaA's BTK drug hits in Phase 2 MS study
- Multiple sclerosis patients taking an experimental drug from Merck KGaA experienced meaningful reduction in lesions characteristic of the disease, according to clinical data announced Wednesday.
- The data come from a Phase 2 study testing the German pharma's evobrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, as a treatment for relapsing multiple sclerosis. Evobrutinib met the study's primary objective, significantly curbing gadolinium enhancing T1 lesions after 12, 16, 20 and 24 weeks compared to placebo.
- Merck KGaA said the trial is ongoing, and additional data will help the company determine the next steps for its drug.
Neuroscience isn't German Merck's forte. A quick glance at the company's pipeline reveals its key focuses really lie in immunology, oncology and, unsurprisingly, immuno-oncology.
But if there was one disease to go after in neuroscience, multiple sclerosis wouldn't be a bad choice. Drugs like Biogen Inc.'s Tecfidera (dimethyl fumarate) and Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer acetate) each raked in around $4 billion last year. There's also room for growth; research firm GlobalData estimates the multiple sclerosis therapy market will have a compound annual growth rate of 2.9% over the next several years and reach $25.3 billion in 2026.
That potential for profit has brought many pharmas and products into the space. To adequately compete, Merck KGaA needs a solid safety and efficacy profile for evobrutinib. So far, it's not entirely clear whether the company has it.
Merck KGaA didn't disclose much in a March 7 statement about the Phase 2 study, other than its drug met the primary endpoint.
What evobrutinib does have going for it, at the very least, is its mechanism of action. BTK inhibitors have already proven very effective and profitable in other disease settings.
For instance, Johnson & Johnson and AbbVie Inc.'s Imbruvica (ibrutinib) secured Food and Drug Administration approval for several kinds of lymphoma, chronic lymphocytic leukemia and chronic graft-versus-host disease. In 2017, J&J recorded $1.89 billion worth of revenue from the drug while AbbVie booked $2.57 billion.
Fellow big pharma Sanofi SA has shown interest in BTK inhibitors as well, shelling out $40 million upfront and putting another $756 million in milestone payments on the line to develop Principia Biopharma Inc.'s multiple sclerosis candidate PRN2246. A few months before that deal, Loxo Oncology Inc. also agreed to pay $40 million to acquire RedX Pharma plc's BTK program.
In addition to multiple sclerosis, Merck KGaA is investigating evobrutinib in patients with rhematoid arthritis and systemic lupus erythematosus.
- Merck KGaA Press release
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