Fenebrutinib Maintains Low Levels of Multiple Sclerosis Activity for 96 Weeks
Although there is no cure for MS, treatment focuses on recovery from attacks, reducing relapse, slowing disease progression, and managing multiple sclerosis symptoms.
Fenebrutinib maintains no disability progression and low levels of disease activity at 96 weeks for patients with relapsing multiple sclerosis (RMS). The latest results from the phase 2 FENopta open-label extension were presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Phoenix, Arizona.1
Although there is no cure for MS, treatment focuses on recovery from attacks, reducing relapse, slowing disease progression, and managing multiple sclerosis symptoms. | Image Credit: ralwel - stock.adobe.com
“These data show that patients treated with fenebrutinib experienced an annualized relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,” Levi Garraway, MD, PhD, chief medical officer and head of global product development, said in a news release.1 “Fenebrutinib is potent, highly selective, and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year.”
MS is a neurological condition that occurs when the protective covering of nerves causes numbness, weakness, trouble walking, and vision changes. The cause of MS is not known, but it is considered an immune-mediated disease. Risk factors can include being a woman, a family history, contraction of the Epstein-Barr virus, being white, living in a temperate climate, having low vitamin D levels, obesity, thyroid disease, pernicious anemia, psoriasis, type 1 diabetes, inflammatory bowel disease, and smoking.2
Although there is no cure for MS, treatment focuses on recovery from attacks, reducing relapse, slowing disease progression, and managing MS symptoms. Corticosteroids and plasma exchange can be used during an attack, and teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam), fingolimod (Gilenya), ozanimod (Zeposia), and others can be used to reduce relapses.2
There were 99 patients entered in the open-label extension trial, with 93 completing it after 96 weeks. Patients who were treated with fenebrutinib for up to 96 weeks had a lower annualized relapse rate of 0.06 and no disability progression. Fenebrutinib suppressed disease activity in the brain, and there was no new T1 gadolinium-enhancing (T1-Gd+) lesion, which correlates to active inflammation. Investigators also reported that patients who switched from the placebo to active treatment had an annualized rate of new or enlarging T2 lesions decreasing from 6.72 at 12 weeks to 0.34 at 96 weeks.1
In the double-blind study, investigators enrolled patients with RMS, who received randomized treatment of either fenebrutinib 200 mg twice daily or the placebo for 12 weeks. The primary end point was the total of new T1-Gd+ lesions at weeks 4, 8, and 12. Secondary end points included the treatment effect on the number of MRI lesions and safety.3
Of the 106 patients evaluated by MRI, 70 received fenebrutinib and 36 received the placebo. At weeks 4, 8, and 12 combined, patients receiving fenebrutinib had a 69% reduction in total new T1-Gd+ lesions and a 74% reduction in new/enlarging T2 lesions compared with patients receiving the placebo. The relative reductions for lesions were 92% and 90%, respectively, at week 8 and 90% and 95%, respectively, at week 12.3
The open-label results showed that there were no new safety concerns, with the most common adverse events being COVID-19, urinary tract infection, pharyngitis, and respiratory tract infection. Serious AEs occurred in 2 patients, including asymptomatic alanine aminotransferase elevation.1
Currently, the company is leading 3 phase 3 trials, including FENhance 1 and 2. The data for these trials are expected at the end of 2025.1
READ MORE: Neurology Resource Center
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REFERENCES
1. Roche’s fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis. News release. Roche. May 29, 2025. Accessed May 30, 2025. https://www.roche.com/media/releases/med-cor-2025-05-30
2. Mayo Clinic. Multiple sclerosis. November 1, 2024. Accessed May 30, 2025. https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269
3. Bar-Or A, Dufek M, Budincevic H, Drulovic J, et al. Impact of Fenebrutinib Treatment on MRI Outcomes and Cerebrospinal Fluid Penetrance in Multiple Sclerosis: Results from the Phase II FENopta Study (S31.004). April 9, 2025. doi:https://doi.org/10.1212/WNL.0000000000205299
