Emrusolmin Fast Tracked for Multiple System Atrophy

The Food and Drug Administration (FDA) has granted Fast Track designation to emrusolmin (TEV-56286) for the treatment of multiple system atrophy (MSA), a rare neurodegenerative disorder.

In patients with MSA, abnormal deposits of the α-synuclein protein in oligodendroglial cells and in certain nerve cells result in slowed movement and/or rigidity, autonomic instability, and impaired balance and/or coordination. Emrusolmin is expected to improve symptoms of MSA by targeting alpha synuclein oligomers.

The investigational oral agent is currently being evaluated in a phase 2, randomized, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT06568237) in adults diagnosed with clinically possible or clinically probable MSA. 

The primary endpoint of the study is the change from baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) part 1 score at week 48. The Modified UMSARS part 1 measures disease progression in MSA based on 11 items that are scored on a scale from 0 (no impairment) to 3 (severe impairment).

There are currently no FDA-approved treatments that address the underlying disease progression of MSA. The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening diseases where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.

This article originally appeared on MPR