MS news notes: Frexalimab, vidofludimus calcium, Briumvi

Columnist Ed Tobias comments on the week's top MS news

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by Ed Tobias |

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Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening:

Is CD40L a better way to control MS inflammation?

CD40L is a protein that’s involved with activation of certain immune cells. The MS News Today story “2nd generation CD40L blocker safely reduces new lesions in Phase 2 trial” reports on tests of an experimental anti-CD40L antibody therapy called frexalimab.

Experimental anti-CD40L treatments aren’t new, as they’ve been studied for 20 years. But the development of these treatment candidates had been stopped during Phase 2 clinical testing because some test subjects experienced serious blood clots. Frexalimab, however, appears to quickly reduce MS activity without the previously experienced side effects.

All disease-modifying therapies (DMTs) approved for MS have side effects, of course, and some more serious than others. Unfortunately, I think that these side effects can sometimes scare away folks from some very useful treatments. Hopefully, if eventually approved, frexalimab could tip the risk-benefit scale more to the benefit side.

According to the story, Sanofi, the company developing frexalimab, plans to launch follow-up clinical trials early next year. If data from those trials are positive, the next step would be applications for the treatment’s regulatory approval.

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Encouraging safety results for vidofludimus calcium

Another experimental treatment designed to reduce MS inflammation is vidofludimus calcium (IMU-838). As detailed in “Vidofludimus calcium tolerated well for nearly 4 years,” an extension study has shown this oral treatment to be safe and well tolerated, with only about 5.3% of study participants discontinuing each year, which is a low percentage.

Vidofludimus calcium is one of the few experimental MS medications being tested on people with relapsing MS, along with those who have the progressive form. That’s important, because over the years, people with progressive MS have had few DMTs to choose from. In the U.S., the only DMT approved for primary progressive MS is Ocrevus (ocrelizumab), and the sole approved therapy for nonactive secondary progressive MS is mitoxantrone.

Immunic Therapeutics, the company developing vidofludimus calcium, is currently running two placebo-controlled Phase 3 trials in adults with relapsing MS and active secondary progressive MS. Each is recruiting about 1,050 patients.

Looking at myelin under a powerful microscope

An interesting possible approach to treating MS involves something researchers are seeing through the lens of an electron microscope. The story “Myelin defects seen before lesions, inflammatory activity in MS: Study” details research using that powerful microscope to look at the myelin coating on nerves in the brain. Scientists found that with MS patients, the myelin was less compact than in patients without MS. Researchers think this may make areas of the brain more susceptible to damage and to the formation of MS lesions.

The next step, according the story, is to see if something can be done to prevent the myelin from loosening around the nerves. They believe that this might one day lead to the ability to prevent the development of MS lesions.

Briumvi becomes third CD20-inhibitor approved in the EU

Disease-modifying therapies that destroy B-cells are considered to be highly effective MS treatments. So I’m sure people with MS living in the European Union are pleased that Briumvi (ublituximab) is joining Ocrevus (ocrelizumab) and Kesimpta (ofatumumab) as approved DMTs. Details of the approval are reported in “Briumvi approved in Europe for active, relapsing forms of MS.”

After a first infusion lasting four hours, further treatment with Briumvi requires only one hour. That’s a quality-of-life benefit compared with Ocrevus’ four-hour infusion, and it’s a much shorter in-chair time than the eight-hour infusions required for my treatments with Lemtrada (alemtuzumab).

Briumvi was approved in the U.S. late last year. It’s expected to be commercially available in Europe sometime later this year.

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.


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