Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS).
The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo.
MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide.
Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease.
Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which work by selectively blocking the cells that drive the autoimmune reaction behind MS.
Fenebrutinib is a dual inhibitor of both B-cell and microglia activation, which Roche says “has the potential to reduce both MS disease activity and progression”.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “I am encouraged by this clinical data for fenebrutinib, which is important news for people living with MS.
“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.’’
Fenebrutinib is one of multiple BTK inhibitors being developed to slow the progression of MS, but the drugs have sparked concerns over liver toxicity.
Last month, Merck KGaA’s BTK inhibitor evobrutinib was put on partial clinical hold by the US Food and Drug Administration (FDA) following two reports of drug-induced liver injury.
The regulator placed similar partial clinical holds on a late-stage trial testing Sanofi’s rival candidate tolebrutinib, as well as Biogen and InnoCare’s phase 2 orelabrutinib.
Fenebrutinib has yet to be hit by any FDA restrictions, and the phase 3 clinical trial programme assessing the drug in RMS and primary progressive MS is ongoing.