Roche's Genentech has announced that its phase 3 trial FENhance has met its primary endpoint, demonstrating that fenebrutinib significantly reduces relapses in relapsing multiple sclerosis (RMS).
The clinical study is the last of three in the clinical development program. FENhance 1 showed a reduction in relapses of 51% compared to teriflunomide, which is similar to FENhance 2, where the reduction was 59%. This is equivalent to one relapse every 17 years. The other clinical trial, FENtrepid, tested the drug in patients with primary progressive multiple sclerosis (PPMS) and also had positive results.
Fenebrutinib is an investigational Bruton’s tyrosine kinase (BTK) inhibitor with high potency, selectivity, and reversibility. It targets both B cells to control acute inflammation that leads to relapses and microglia to prevent chronic damage in the brain that appears to be responsible for long-term disability progression. It is currently the only high-efficacy, brain-penetrant treatment for RMS and PPMS.