Roche reveals more mid-stage data for BTK inhibitor in relapsing multiple sclerosis

Roche recently announced promising Phase 2 data for its BTK inhibitor, fenebrutinib, in treating relapsing multiple sclerosis (MS). The findings revealed that patients treated with fenebrutinib exhibited minimal disease activity and no progression in disability over the course of one year.

This announcement follows closely on the heels of Sanofi’s release of mixed results for its BTK inhibitor, tolebrutinib, specifically highlighting the drug’s failure in relapsing multiple sclerosis patients. Analysts at B. Riley had previously suggested that tolebrutinib’s underperformance might signal the end for BTK inhibitors in treating this form of MS. However, Roche, along with other companies like Novartis, continues to pursue late-stage trials for these treatments, while Merck KGaA has already exited the competition earlier this year.

Roche's Phase 2 trial results for fenebrutinib showed that 96% of patients experienced no relapses at the one-year mark in the open-label extension study. The annual relapse rate was recorded at 0.04, with no observed changes in disability over 48 weeks. This was assessed using the Expanded Disability Status Scale, a standard measure for disability in multiple sclerosis.

The company also reported that fenebrutinib effectively suppressed disease activity in the brain. An impressive 99% of patients were free of T1 gadolinium-enhancing lesions, a marker of active inflammation, and there was a threefold reduction in lesion volume compared to patients receiving a placebo.

Regarding safety, the most common adverse events among patients were urinary tract infections, Covid-19, and pharyngitis. There was only one reported case of a serious adverse event. Additionally, in the open-label phase of the trial, a single patient experienced asymptomatic alanine aminotransferase elevation, which was resolved upon discontinuation of the treatment. This incident is noteworthy as the drug had previously been placed on partial hold due to potential liver issues.

Levi Garraway, Roche’s Chief Medical Officer and head of product development, commented on the findings, stating that if these Phase 2 results are validated in the ongoing Phase 3 trials, fenebrutinib could significantly advance the treatment options available for people living with multiple sclerosis.

Currently, Roche is conducting three Phase 3 trials for fenebrutinib: the FENhance 1 and 2 trials, focusing on relapsing multiple sclerosis, and the FENtrepid trial, which is investigating the drug’s effects on primary progressive multiple sclerosis. The data from these trials are anticipated to be available next year.

Roche had initially hinted at the positive outcomes of its Phase 2 trials last year, indicating that fenebrutinib was associated with reduced brain lesions and had successfully met both its primary and secondary endpoints.

In summary, Roche’s new data on fenebrutinib presents a hopeful outlook for the treatment of relapsing multiple sclerosis, especially in light of other companies’ struggles with similar BTK inhibitors. The medical community eagerly awaits the results of the ongoing Phase 3 trials to confirm these findings and potentially pave the way for a new, effective treatment for multiple sclerosis.