Roche presented new results from a pivotal study on the experimental drug fenebrutinib at the Actrims conference in California.
The active ingredient slowed the progression of disability in patients with primary progressive multiple sclerosis (PPMS) at least as effectively as the only approved Roche therapy to date, Ocrevus.
Fenebrutinib reduced the risk of worsening disability by 12 percent compared to Ocrevus, Roche announced on Saturday evening. The first differences became apparent after just 24 weeks, as shown by the data from the FENtrepid study. The benefit was particularly clear in upper extremity function, where the risk of deterioration was reduced by 26 percent.
According to the information, the side effects were overall comparable to the existing therapy. Elevated liver enzymes occurred more frequently with fenebrutinib but were transient and reversible. Severe side effects were observed at similar rates in both treatment groups.
The data presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) follows Roche’s announcement in November 2025 that the FENtrepid trial and the first of two Phase III trials in relapsing-remitting multiple sclerosis (RMS) (FENhance 2) met their primary endpoints.
As soon as the results of the second RMS study (FENhance 1) are available, which is expected for the first half of 2026, the data from all phase III studies with fenebrutinib will be presented to the regulatory authorities, Roche announced.
Fenebrutinib is a new, experimental active ingredient against multiple sclerosis that is taken as a tablet and goes directly to the brain. It specifically blocks an enzyme called BTK, which plays an important role in inflammation. Unlike many other drugs in this class, fenebrutinib binds to the enzyme temporarily rather than permanently – which could reduce side effects.
According to Roche, fenebrutinib has a highly selective effect: it almost exclusively hits its target without disrupting other enzymes. It affects B cells in the blood, which are responsible for acute inflammation, and microglia in the brain, which cause chronic damage that leads to long-term disability.
/hr/cg/AWP/mis
BASEL (dpa-AFX)
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