Teva’s Emrusolmin Granted Fast Track Designation for Multiple System Atrophy

Eric Hughes, MD, PhD

According to a new announcement, the FDA has granted fast track designation to Teva Pharmaceuticals’ emrusolmin, a small-molecule modulator of protein aggregation, as a potential treatment for multiple system atrophy (MSA), a movement disorder with no approved therapies. The agent is currently being assessed in a phase 2 study (NCT06568237) that is expected to conclude in early 2027.¹

Emrusolmin, otherwise known as TEV-56286, specifically targets alpha-synuclein oligomers, toxic protein assemblies widely believed to drive neurodegeneration in MSA. The belief is that by preventing clumping of α-synuclein, emrusolmin may modify the disease course rather than simply alleviating symptoms. This oral, small molecule therapy has shown an ability to inhibit α-synuclein aggregation at clinically relevant concentrations in MSA-relevant in vitro preclinical models.

"Multiple System Atrophy is a devastating and rapidly progressive neurodegenerative disorder with no cure," Eric Hughes, MD, PhD, executive vice president of Global R&D, and chief medical officer at Teva, said in a statement. "The promising potential of emrusolmin is a testament to what we are building at Teva – a pipeline that truly meets patients’ needs and strategic partnerships that drive innovation."

Teva is currently conducting a phase 2 study testing the safety, tolerability, and efficacy of emrusolmin in an estimated cohort of 200 patients with MSA. The planned study period is 56 weeks including a screening period, a 48-week double-blind treatment period, and a follow-up visit, lasting a total of 27 months. Enrolled patients will receive emrusolmin capsules once daily or matching placebo, with change in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part 1 as the primary outcome measure.

Other secondary end points for the study include change in total UMSARS score for Part I and II combined, as well as change in Clinical Global Impression Scale-Severity and Multiple System Atrophy-Quality of Life score. Investigators will also record safety information, such as treatment-emergent adverse events, number of patients withdrawing because of AEs, clinically significant abnormal vital sign value, and number of patients with at least 1 potentially clinically significant change in 12-lead electrocardiogram findings.

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"We are pleased to announce this next step in our collaboration with Teva, an organization that has longstanding expertise in the development of neuroscience therapeutics," Torsten Matthias, chief executive officer at MODAG, said in a statement. "This Fast Track Designation further underscores the potential of our therapeutic candidate to help patients living with MSA."

Otherwise known as TOPAS-MSA, the phase 2 study includes those with clinically possible or clinically probably MSA, as defined by the Gilman criteria, who can walk at least 10 meters independently. Participants must be medically and psychiatrically stable, and the study does not allow pregnant women.²

Patients with two or more relatives with MSA, recent participation in another investigational drug study, or a history of alcohol or substance abuse in the past year are excluded from the trial. Additional exclusions include pregnancy, breastfeeding, hypersensitivity to study drugs, vulnerable populations such as incarcerated individuals, and the use of prohibited concomitant medications during restricted windows.

REFERENCES
1. Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy. News release. Teva Pharmaceuticals. September 9, 2025. Accessed September 9, 2025. https://www.tevapharm.com/news-and-media/latest-news/tevas-emrusolmin-granted-u.s.-fda-fast-track-designation-for-treatment-of-multiple-system-atrophy
2. A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study (TOPAS-MSA). Clinicaltrials.gov. Updated August 26, 2025. Accessed September 9, 2025. https://clinicaltrials.gov/study/NCT06568237