Evobrutinib Demonstrates Sustained Clinical Benefit for Up to Five Years in Patients with Relapsing Multiple Sclerosis

Recently, EMD Serono, the healthcare business sector of Merck & Co., Inc. (MSD) in the United States and Canada, announced new five-year data from an open-label extension (OLE) Phase II clinical trial. The data showed that relapsing multiple sclerosis (RMS) patients treated with the investigational BTK inhibitor (BTKi) evobrutinib maintained a consistently low annualized relapse rate (ARR), and a significant proportion of patients showed no signs of clinical worsening.

Image Source: Biospace

Evobrutinib is an orally administered, highly selective BTK inhibitor with strong central nervous system (CNS) penetration. It is currently under clinical development as a potential treatment for relapsing multiple sclerosis (RMS). Evobrutinib is the first BTK inhibitor to demonstrate clinical efficacy in the largest Phase II study, with follow-up exceeding three years, and has shown modulation of early biomarkers of central inflammation associated with disease progression, including slowly expanding lesion (SEL) volume and levels of neurofilament light chain (NfL) in the blood. Evobrutinib aims to modulate B-cell responses, such as proliferation, antibody and cytokine release, as well as regulate the activation of macrophages/microglia.

Multiple Sclerosis is a chronic inflammation of the central nervous system and the most common non-traumatic disabling neurological disease among adolescents. It is estimated that approximately 2.9 million people worldwide are living with multiple sclerosis. Symptoms of multiple sclerosis vary, but the most common ones include blurred vision, numbness or tingling in the limbs, and problems with strength and coordination.

Other patient-reported data from the study show that patients' mental health and vitality (closely related to fatigue) have significantly improved in both statistically and clinically meaningful ways. These data will be presented at the 9th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and the Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS 2023).

Jan Klatt, Senior Vice President and Head of Neurology & Immunology Development at EMD Serono, stated that the data presented at the ECTRIMS-ACTRIMS meeting further demonstrate the sustained safety and efficacy of evobrutinib and highlight its potential to reduce fatigue in RMS patients. Evobrutinib also has the potential to directly address inflammation in RMS, a previously underestimated factor contributing to disease progression that current treatments have not fully resolved. These study findings continue to reinforce confidence in evobrutinib’s ability to address key unmet needs in current RMS treatment options.

Data from the ongoing OLE II phase trial show that evobrutinib has demonstrated sustained clinical efficacy and safety over five years of treatment, with no new safety signals observed. By the fifth year, 87.1% of patients showed no signs of clinical worsening (defined as no relapses and no disease progression). During the OLE period, the evobrutinib dosage was adjusted from 75 mg once daily to 75 mg twice daily, further reducing ARR. The overall ARR remained at a low level of 0.11.

Overall, treatment-emergent adverse events (TEAEs) in the OLE were mild/moderate, with 3.3% (n=7) of RMS patients experiencing serious TEAEs.

Notably, in April this year, the U.S. FDA announced a partial hold on the Phase III trial of Evobrutinib in Germany after two multiple sclerosis (MS) patients showed signs of liver injury.

Globally, there are five approved BTK inhibitors on the market. Apart from Ibrutinib, the remaining four are second-generation BTK inhibitors: AstraZeneca's Acalabrutinib (approved in 2017), BeiGene's Zanubrutinib (approved in 2019), Ono Pharmaceutical/Gilead's Tirabrutinib (approved in 2020), and InnoCare Pharma's Orelabrutinib (approved in 2020). Evobrutinib is currently in clinical research, and it has not been approved in any region worldwide.

Source:

Editor: Pea Shooter

Disclaimer: This article is an integrated content and does not represent the views of this platform. If it involves issues related to the content, copyright, or other problems, please leave a message on this platform, and we will handle it promptly.