Oral Bruton’s tyrosine kinase inhibitor reduced brain lesions in phase 2 MS trial
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Key takeaways:
- Fenebrutinib met primary and secondary endpoints in reducing MRI markers of MS disease activity compared with placebo.
- No new safety concerns were reported, consistent with previous and ongoing clinical trials.
Genentech announced positive results from its global phase 2 study evaluating the investigational oral Bruton’s tyrosine kinase inhibitor fenebrutinib in adults with relapsing forms of MS.
According to a company release, fenebrutinib met its primary and secondary endpoints in the FENopta trial — a randomized, double-blind, 12-week study to investigate safety, efficacy and pharmacokinetics in 109 adults aged 18 to 55 years with relapsing forms of MS. The investigational BTK inhibitor, which inhibits both B-cell and microglia activation, significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared with placebo, while also significantly reducing the total number of new or enlarging T2 brain lesions.
Further, a higher proportion of patients treated with fenebrutinib were free from new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions compared with placebo, the company stated. Preclinical data also demonstrated fenebrutinib was potent and highly selective.
The release additionally stated there were no new safety issues reported for fenebrutinib in the FENopta trial, and its safety profile was consistent with previous and current clinical trials.
“I am encouraged by this clinical data for fenebrutinib, which is important news for people living with MS,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, said in the release. “Fenebrutinib’s mechanism of action, which can inhibit both B cells and microglia, has the potential to both reduce MS disease activity, such as relapses, and also impact disease progression.”
The phase 3 fenebrutinib clinical trial program for relapsing MS and primary progressive MS is ongoing, the company stated.