Could BTK Inhibitors Be the Next Big MS Treatment?

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by Ed Tobias |

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Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is.

Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells drive the abnormal immune responses that characterize MS. Researchers hope the medication will lower inflammation and slow progression of all forms of MS, as Multiple Sclerosis News Today‘s Marta Figueiredo noted.

Orelabrutinib was developed as a cancer drug, but it began a Phase 2 clinical trial in March to judge its safety and efficacy as a treatment for relapsing-remitting MS. Biogen has bought the rights to globally distribute the medication as an MS drug. According to a Biogen press release, if certain development and sales goals are met, Biogen will pay up to an additional $812.5 million to InnoCare Pharma, the Chinese company that developed the medication, plus royalties.

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Biogen Strikes Deal for Orelabrutinib, Now in Phase 2 Trial

Other BTKi tests underway

Orelabrutinib isn’t the only BTK inhibitor in the research pipeline. Sanofi has tolebrutinib (previously known as SAR442168), Roche is studying fenebrutinib, and EMD Serono (Merck KGaA outside North America) is investigating evobrutinib. All are in Phase 3 trials.

Small and selective

The big deal about BTK inhibitors seems to be that they can selectively target B-cells, wiping out those that harm the immune systems of people with MS while leaving normal B-cells alone. (Disease-modifying therapies such as Ocrevus (ocrelizumab) and rituximab wipe out all of the B-cells, leaving a greater chance of infection.)

“That’s important. That’s what you want,” Peggy Kendall, an allergist and immunologist at Washington University School of Medicine, told the journal Nature Biotechnology.

BTK inhibitors are small molecules. According to University of California, San Francisco neurologist Stephen Hauser, also quoted in Nature Biotechnology, this fact allows them to get into parts of the nervous system that other antibodies have a tough time reaching.

Hauser even used the “C-word,” telling the journal’s Elie Dolgin that if small-molecule therapies can “knock out the adaptive inflammation that’s overactive in the nervous system, I think we can really cure MS.”

Could that really be true?

That’s a pretty powerful prediction. No wonder several pharmaceutical companies have their research eyes on BTK inhibitors and are willing to pay big bucks to carve out a piece of this pie. I’m not a scientist or a doctor, so I can’t judge whether or not “we can really cure” is just hyperbole. But let’s hope that working with BKTi’s at least leads us in that direction, and that the cost of developing them won’t push their price tag into the stratosphere.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.


Merja Kangas avatar

Merja Kangas

How many different names on medication does it take to finally put an end to MS? It's kind of same old, same old...
Struggling with fatigue, depression and ppms I am at the end of my rope.

Ed Tobias avatar

Ed Tobias

Hi Merja,

I'm sorry that you're struggling with PPMS. But I always try to look on the bright side. This research seems to be more than just a different's a different treatment process. As far as I'm concerned, the more different ways researchers try attack our MS the better. I hope you agree.


Terry Rose avatar

Terry Rose

I call my symptoms the drunk walk.

Ed Tobias avatar

Ed Tobias


As do many of us. That's why the title of a little book I've written is "We're Not Drunk, We Have MS." It's also the name of a Facebook MS group.


Denise avatar


My feeling exactly. All I do is read and read and read and still nothing is getting done or should I say fast enough.

Terry Thompson-Manning avatar

Terry Thompson-Manning

We must be at the same party???

Ellen Burroughs avatar

Ellen Burroughs

BTK? Wasn't that the nickname of the serial killer some years back? And it's from China? I'm going to be very wary of this one!

Terry Thompson-Manning avatar

Terry Thompson-Manning

Merja, I understand your frustration. I just turned 65, and was diagnosed in 1988….that’s over half my life. There was nothing available outside of steroids at that time, and I had plenty. Although they have made great strides, my hope was there would be a cure by now. Instead, there are repercussions to my earlier Prednisone therapies that keep me hopping instead like severe osteoperosis and squamous cancers. So the baby steps they do take, and the drugs introduced more rapidly than ever before, are infinitely better than the steroid treatment used in the past that can have very long term effects.

Ed Tobias avatar

Ed Tobias

Well put, Terry. Thanks for taking the time to share those comments.


Lisa Taanquist avatar

Lisa Taanquist

If I had a penny for each time I have read there's a breakthrough, I would have been very rich now. I'll believe it when I see it.

Jenny Ferguson avatar

Jenny Ferguson

Great article, glad I found you. You may be interested in Prof Giovannoni selfie blog on Substack. He also is an m s specialist at The London and Barts hospitals, a great advocate and thinker. Worth reading. I have SPMS now , diagnosed in 92

Suzette Audiss avatar

Suzette Audiss

My 19 year old was
Diagnosed when she was 17 started Tsabri 27 mis ago and now has JCV positive so she’ll be switching medications probably Ocrevus. If this new possibility comes to
Fruition I wonder if she would be eligible. She’s college student athlete ERAU 3.9gpa thanks to Tsabri now we worry about
Concerned Mom

Anthony Hoysted avatar

Anthony Hoysted

Sounds good, but too late for me, I think! (SPMS, EDSS 6.5) I still look on the bright side.

Alison McLachlan avatar

Alison McLachlan

Mr Tobias,
You stick resolutely to your positivity (go for it!) and in that I share your views. Let's all hope that they break through with this one, it's a Biggie! They're sure to one day!

Ed Tobias avatar

Ed Tobias

Thanks, Alison. Fingers crossed!



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