Roche’s fenebrutinib achieved positive results in a Phase II clinical trial in patients with relapsing forms of multiple sclerosis (RMS), meeting the trial’s primary and secondary endpoints.

The primary endpoint of the trial measured the total number of new gadolinium-enhancing T1 brain lesions observed on MRI scans of the brain at week 12. Fenebrutinib demonstrated a significant reduction of new gadolinium-enhancing T1 lesions.

The drug also reduced the total number of new or enlarging T2 brain lesions, which was the secondary endpoint. In addition, a higher proportion of patients in the treatment cohort were free from any new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions.

T1 lesions are a marker of an active inflammation, while T2 lesions represent the amount of disease burden or lesion load.

As for safety, there were no safety concerns identified in the trial. Fenebrutinib retained its safety profile that was established in previous and ongoing clinical trials.

Fenebrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor. BTK is an enzyme that regulates B cell development and activation and is involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia.

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Roche’s chief medical officer and head of global product development Dr Levi Garraway said: “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 II trial (NCT05119569) investigated the efficacy, safety and pharmacokinetics of fenebrutinib compared to a placebo. The objective of the trial was to characterise the effects of fenebrutinib on MRI and soluble biomarkers of disease activity and progression.

The trial enrolled 109 patients between the ages of 18 and 55 with RMS. Patients who completed the double-blind period are eligible for an open-label extension study.

Phase III trial development

In 2020, Roche launched a Phase III clinical trial programme to investigate fenebrutinib in patients with multiple sclerosis (MS).

The Phase III programme consists of two identical Phase III trials, FENhance 1 (NCT04586010) and FENhance 2 (NCT04586023), where fenebrutinib is compared to teriflunomide in patients with RMS. Both trials are currently recruiting, with an estimated enrolment of 736 patients in each.

Roche is also recruiting patients into another Phase III trial (NCT04544449) comparing fenebrutinib to Ocrevus (ocrelizumab). The trial expects to enrol 946 patients with primary progressive MS (PPMS). The US Food & Drug Administration (FDA) approved Ocrevus for various forms of MS in 2017.