The director of the UCSF Weill Institute for Neuroscience spoke to the advantages of having agents that can be used across the spectrum of MS, and the role disease progression plays early on.
“The rubber meets the road when our ideas are tested in the clinical area, and one would never have expected a primacy of B cells in the MS pathway were it not for the B-cell therapeutics.”
At MS Virtual 2020, the 8th Joint ECTRIMS-ACTRIMS meeting, September 11–13, 2020, a presentation was given that detailed the upcoming phase 3 assessment of fenebrutinib, an investigational Bruton Tyrosine Kinase (BTK) inhibitor, in both relapsing and primary progressive multiple sclerosis (MS). There will be 2 trials in relapsing disease and 1 in progressive, with 1:1 randomization and estimated enrollment of 734 patients in each of the relapsing MS trials and 946 in the primary progressive MS trial.
All 3 trials aim to assess the agent’s impact on disease progression, and thus will feature 12-week composite Confirmed Disability Progression (cCDP12) as a primary end point—the relapsing trials will also include annualized relapse rate as a co-primary end point. Assessment with cCDP12 requires at least an increase in Expanded Disability Status Score (EDSS) score of ≥1.0 point from a baseline score of ≤5.5 points, or a ≥0.5 point increase from a baseline score of >5.5 points; a 20% increase from baseline in time to complete the 9-Hole Peg Test; or a 20% increase from baseline in the Timed 25-Foot Walk Test.
In this interview with NeurologyLive, Stephen L. Hauser, MD, professor of neurology, and director, UCSF Weill Institute for Neurosciences, who presented the details of these trials, spoke to the driving theory behind BTK inhibition in MS, and how fenebrutinib may play a role as a particularly specific inhibitor, unlike other agents in its class.
For more coverage from MS 2020, click here.