Roche Highlights Phase II MS Data Following Sanofi's Late-Stage Setbacks

Days after Sanofi experienced setbacks with its BTK inhibitor, Roche announced a significant achievement with its own BTK inhibitor, fenebrutinib. On Wednesday, Roche revealed open-label extension data from its Phase II FENopta study, showcasing nearly complete suppression of disease activity in patients with relapsing multiple sclerosis (MS).

The FENopta study results were promising, showing that 99% of the patients treated with fenebrutinib did not exhibit T1 gadolinium-enhancing lesions, which are critical markers of inflammation, at 48 weeks. Moreover, during the open-label extension (OLE) phase, patients experienced three times the reduction in the volume of T2 lesions—indicative of chronic disease burden—compared to the study's double-blind phase.

Regarding safety, the adverse events reported during the OLE period were consistent with earlier reports. The most common side effects included urinary tract infections, COVID-19, and pharyngitis. The OLE also noted one asymptomatic case of alanine aminotransferase elevation, which resolved after discontinuing fenebrutinib treatment.

"We are encouraged by these results," said Roche CMO Levi Garraway. "Our BTK inhibitor suppressed almost all disease activity and disability progression in multiple sclerosis patients after a year of treatment. If these findings are validated in late-stage studies, fenebrutinib could significantly advance the treatment landscape for MS."

Roche plans to present comprehensive data and analyses from the FENopta study at the upcoming European Committee for Treatment and Research in Multiple Sclerosis congress in Denmark later this month.

The announcement follows Sanofi's recent disclosure that its BTK blocker, tolebrutinib, failed to achieve significant improvements in annualized relapse rates in Phase III studies GEMINI 1 and GEMINI 2 for relapsing MS. However, Sanofi's Phase III HERCULES study did meet its primary endpoint, highlighting the potential of tolebrutinib in treating non-relapsing secondary progressive multiple sclerosis (nrSPMS). Sanofi's R&D head, Houman Ashrafian, indicated that future efforts might focus on nrSPMS, though no formal announcement has been made.

This potential refocusing by Sanofi could present an opportunity for Roche, which is currently conducting the Phase III FENhance 1 and FENhance 2 studies to evaluate fenebrutinib in relapsing MS. Roche is also assessing the BTK inhibitor in primary progressive MS through the late-stage FENtrepid trial, with readouts expected by the end of 2025.

Designed for oral administration, fenebrutinib targets the BTK enzyme, which plays a role in regulating B cell development and activation. This regulation facilitates the activity of innate immune system cells such as macrophages and microglia. By inhibiting this protein, fenebrutinib can mitigate MS disease activity and slow down the progression of disability.

In December 2023, the FDA placed a partial clinical hold on fenebrutinib’s MS program due to several detected cases of liver injury.

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