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Fasudil attenuates disease spreading in ALS - a post-hoc analysis of the ROCK-ALS trial
Andreas W Wolff1, Andreas Leha2, Jan C Koch2,3
1Clinical Department of Neurology, Klinikum rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Medrxiv : the Preprint Server for Health Sciences
|September 15, 2025
Summary
The ROCK-ALS trial found that fasudil, an investigational drug, may slow the progression of muscle weakness in amyotrophic lateral sclerosis (ALS) patients. This study utilized the Motor Unit Number Index (MUNIX) to track disease spread and assess fasudil
Area of Science:
- Neuroscience
- Clinical Neurology
- Biomarker Research
Background:
- Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease causing widespread muscle weakness.
- Current treatments offer limited efficacy in halting disease progression.
Purpose of the Study:
- To evaluate fasudil, a Rho kinase inhibitor, as an add-on therapy to riluzole in ALS patients.
- To assess fasudil's effect on the spread of lower motor neuron involvement using the Motor Unit Number Index (MUNIX).
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (ROCK-ALS) involving 118 ALS participants.
- MUNIX was measured in 10 muscles at multiple time points to quantify motor neuron integrity and disease spread.
- Correlations between baseline serum biomarkers (NfL, GFAP) and clinical measures were explored for prognostic value.
Main Results:
- Baseline MUNIX scores correlated with subsequent ALSFRS-R decline, indicating prognostic potential.
- Fasudil treatment significantly reduced the number of newly affected muscles at day 90 compared to placebo, in a dose-dependent manner.
- Fasudil demonstrated safety and tolerability as an add-on therapy to riluzole.
Conclusions:
- MUNIX is a sensitive biomarker for monitoring disease progression and spread in ALS.
- Fasudil may attenuate the progression of lower motor neuron involvement in ALS patients.
- Further research into fasudil's therapeutic potential in ALS is warranted.
