Roche touted new Phase 2 data for its BTK inhibitor fenebrutinib in relapsing multiple sclerosis, noting that patients on the drug maintained low levels of disease activity and no progression of the disability for up to one year.
The data come two days after Sanofi’s mixed results for its BTK inhibitor tolebrutinib, with the candidate specifically failing in relapsing multiple sclerosis patients. On Tuesday, B. Riley analysts wrote that given tolebrutinib’s “brain-penetrant potency” versus other BTK inhibitors, Sanofi’s update is a “likely end” to these drugs in relapsing multiple sclerosis. Companies like Roche and Novartis are currently running late-stage trials. Merck KGaA already dropped out of the race earlier this year.
But Roche said Wednesday that 96% of fenebrutinib patients in its Phase 2 trial were free of relapses at one year in the open-label extension study, with an annual relapse rate of 0.04 and no change in disability over 48 weeks, which was measured using the Expanded Disability Status Scale.
Roche added that its treatment suppressed disease activity in the brain, with 99% of patients free of a marker of active inflammation — T1 gadolinium-enhancing lesions — and showing three times more reduction in the volume of the lesions compared to placebo.
The most common adverse events were urinary tract infection, Covid-19 and pharyngitis, and only one patient experienced a serious adverse event. In the open-label part of the trial, one patient experienced an asymptomatic alanine aminotransferase elevation, which resolved when the patient discontinued treatment. The drug was previously placed on partial hold due to possible liver issues.
“If these results are validated in the ongoing Phase III trials, fenebrutinib could further advance the treatment landscape for people living with multiple sclerosis,” Roche CMO and head of product development Levi Garraway said in a statement.
Roche has three ongoing Phase 3 fenebrutinib trials: the FENhance 1 and 2 trials in relapsing multiple sclerosis, and the FENtrepid trial in primary progressive multiple sclerosis. Those data are expected next year.
Roche first hinted at positive Phase 2 results last year, when it said that the drug was linked to reduced brain lesions and met the primary and secondary endpoints.
Editor’s note: The story was updated to add further context.