Emrusolmin · program

Emrusolmin for Multiple System Atrophy

Phase 2RecruitingTeva Pharmaceutical Industries Ltd. (TEVA)
  • Orphan Drug
  • Fast Track

Phase 2 (TOPAS-MSA, NCT06568237): multi-center, double-blind, randomized, placebo-controlled, parallel-group study of oral once-daily emrusolmin (TEV-56286) vs placebo in adults with multiple system atrophy. 48-week double-blind treatment; ~350 participants; primary endpoint change from baseline in Modified UMSARS Part I (non-EU sites) / Total UMSARS (EU sites) at week 48. FDA Orphan Drug designation granted 2022; FDA Fast Track designation granted 2025-09-09. Lead/sole disclosed indication for emrusolmin's pivotal-track development under Teva (PD explored in earlier Phase 1b).

Data current as of

Development timeline

Phase 2Oct 2024 – Sept 2027
  1. UpcomingAnticipated Phase 2 (TOPAS-MSA) topline in multiple system atrophy (primary endpoint: change from baseline in UMSARS at week 48)
  2. Phase 2 TOPAS-MSA (NCT06568237) initiated; study start date 2024-10-02 (actual) per ClinicalTrials.gov; recruiting in MSA.
Phase 1Oct 2021
  1. MODAG GmbH and Teva announced an exclusive worldwide licensing collaboration to develop anle138b (and related sery433) for MSA and Parkinson's disease (October 2021). Earlier first-in-human Phase 1a (healthy volunteers) and a Phase 1b multiple-ascending-dose study in Parkinson's disease (150-300 mg/day) were conducted by MODAG; exact NCT/dates not re-verified here so summarized without fabrication. changed_at is approximate to the licensing announcement (month-level).↗

Readouts

  • 2H 2027AnticipatedTopline dataNCT06568237

    Anticipated Phase 2 (TOPAS-MSA) topline in multiple system atrophy (primary endpoint: change from baseline in UMSARS at week 48)

Clinical trials in Multiple System Atrophy

NCT06568237TV56286-NDG-20039Phase 2Recruitingn=350

A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)

Started Oct 2024· Primary completion Sept 2027

Formulations

FormulationRouteRegimenPharmacokinetics
Emrusolmin oral (300 mg once daily)
300 mg orally once daily (Phase 2 TOPAS-MSA dose); Phase 1 tested single/multiple ascending doses up to 300 mg/day
OralOnce dailyt½ 12 h

Mechanism of action (compound-wide)

Oral, brain-penetrant small-molecule 'oligomer modulator' that binds pathological alpha-synuclein aggregates and interferes with their oligomerization/formation, reducing accumulation of toxic oligomeric species. In MSA (an alpha-synucleinopathy with oligodendroglial alpha-synuclein inclusions), the disease-modifying rationale is modulation of pathological alpha-synuclein. The compound (anle138b) also binds aggregated tau and prion protein in preclinical work, but the MSA program targets alpha-synuclein. Preclinical MSA models showed reduced alpha-synuclein oligomerization, prevented motor decline and neurodegeneration; excellent oral bioavailability and blood-brain-barrier penetration.

TargetActionAffinity
Alpha-synucleinprimarySNCAModulator—ⓘ

← Full Emrusolmin compound page (identity, identifiers, all indications)

Sources

  1. A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy (TOPAS-MSA) (NCT06568237) — ClinicalTrials.gov
  2. Anle138b modulates alpha-synuclein oligomerization and prevents motor decline and neurodegeneration in a mouse model of multiple system atrophy — Movement Disorders (PMC6492169)
  3. Emrusolmin — Therapeutics — ALZFORUM
  4. Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate — Teva