Seema Khaneja MD
Updated on: October 7, 2024 10:48 pm GMT
Roche’s Fenebrutinib Shows Promising Results in Relapsing Multiple Sclerosis Study
Roche’s investigational drug, fenebrutinib, has demonstrated significant potential in treating patients with relapsing multiple sclerosis (RMS), according to preliminary results from a Phase II clinical trial. The findings will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, on September 18, 2024. The one-year study revealed that nearly all participants treated with fenebrutinib experienced a stark reduction in disease activity and no progression of disability.
Study Overview and Results
The recent results stem from the FenOpta study’s open-label extension phase, which enrolled 70 patients. The outcomes are promising, indicating that 96% of patients treated with fenebrutinib were relapse-free at the one-year mark. The study utilized the Expanded Disability Status Scale (EDSS) as a measurement tool, noting a notably low annual relapse rate (ARR) of just 0.04.
Over the course of the previous 12 weeks in the trial, patients on fenebrutinib exhibited a 69% reduction in the occurrence of gadolinium-enhancing lesions compared to those receiving a placebo. At the one-year follow-up, there was a marked decline in inflammatory markers, with 99% of patients remaining free from such lesions. Additionally, the study found a threefold increase in the reduction of T2 lesions, which signify chronic damage, compared to the end of the initial double-blind period.
Safety Profile and Adverse Events
In terms of safety, fenebrutinib maintained a profile consistent with earlier trials. The most frequently reported adverse events included urinary tract infections (8%), COVID-19 (7%), and pharyngitis (5%). Notably, serious adverse events occurred in just one patient (1%), and an asymptomatic elevation in alanine aminotransferase levels emerged in one patient, which resolved upon discontinuation of treatment.
Feedback from Roche Leadership
Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, expressed optimism regarding the current findings. “If these results are confirmed in ongoing Phase III trials, fenebrutinib could further improve the treatment landscape for people with multiple sclerosis,” he stated. These trials are crucial, as they will further explore fenebrutinib’s efficacy and safety profile, expanding potential therapeutic options available to those living with RMS.
Ongoing Trials and Future Expectations
Roche currently has three Phase III clinical trials underway: FENhance 1, FENhance 2, and FENtrepid, which target RMS and primary progressive multiple sclerosis (PPMS). Data from these larger-scale studies is projected to be available by the end of 2025. It is important to note that the Food and Drug Administration (FDA) put a partial clinical hold on fenebrutinib’s MS program earlier this month due to reported liver injuries among trial participants, affecting recruitment within the U.S. but not abroad.
Fenebrutinib works by blocking Bruton’s tyrosine kinase (BTK), an enzyme that is crucial in B-cell development and activity while also influencing microglial activation. This dual inhibition approach could potentially minimize overall disease activity and disability progression in MS patients.
Current Treatment Context for MS
The standard care for an MS relapse typically involves either a five-day course of steroids taken at home or steroid injections in a hospital setting for three to five days. As current treatment options may not address all patient needs, fenebrutinib’s observed efficacy could provide a much-needed alternative in addressing the complexities of managing MS.
Market Projections and Industry Interest
As fenebrutinib progresses through clinical trials, it has attracted considerable attention within the pharmaceutical industry. GlobalData forecasts that the drug could generate sales up to $810 million by 2030, signifying its anticipated impact on the market and the lives of those suffering from multiple sclerosis.
Roche has exciting news from the FenOpta study that shows fenebrutinib could be a big help for people with relapsing multiple sclerosis. This could change how doctors treat this long-lasting and tough disease, but we need to wait for more results from the ongoing Phase III trials to be sure.
