Treatment with the investigational CD40 ligand inhibitor frexalimab significantly reduced new MRI lesions in relapsing multiple sclerosis (MS) by week 24, according to data presented at the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
In this exclusive MedPage Today video, Gabrielle Macaron, MD, from the Université de Montréal in Quebec, discusses the exciting promise seen with new longer-term study data.
Following is a transcript of her remarks:
I heard this from so many other colleagues, like why is it just a poster presentation? This was maybe the only, not only, but one of the main new, exciting things that was presented at ECTRIMS.
And it’s indeed an exciting mechanism of action. It’s really novel, a new soluble CD40 ligand. We already know that it’s higher in progressive MS form, in the plasma of patients who have a progressive MS form. So I think the idea here was to evaluate its efficacy specifically on progression. And if I recall, there was a paper published in Neurology a couple of years ago, and it’s on another molecule. I don’t remember the name of it [toralizumab], but that acts in a similar way. And the study, I think it was a phase I and showed that the drug was well tolerated and was safe.
So yes, I mean, in the study presented by Patrick Vermersch, it was a phase II study and they enrolled 129 patients either to receive high dose, low dose, or placebo. And the primary outcome was the number of new active MRI lesions at week 12. And I think what was presented at ECTRIMS was the open-label extension of this phase II study that was for 24 weeks.
And the results are really exciting, a significant reduction of above 90% of the number of new lesions, specifically in the high-dose arm, and good numbers as well in the low-dose arm at week 12. And this effect persisted in the open-label extension study. And I think in the open-label extension study, patients who were on the placebo arm switched after 12 weeks to frexalimab, and it really worked as well.
I think it’s an exciting study. It has generally a good safety profile. Most patients had minor upper respiratory tract infections and headaches, COVID-19 infections, and I don’t think there were any signs of worrisome of severe lymphopenia or hypogammaglobulinemia or something like that.
I think we still need to see the long-term results specifically on disability worsening. It’s a promise that we want to see … I think also for BTK [Bruton’s tyrosine kinase]. I think we’re not impressed anymore by a reduction of 90% of gadolinium-enhancing lesions. We need more than that. So if the promise with this and with BTK inhibitors is to act on mechanisms of tissue injury, that would be really exciting. But it’s going to take time.