Teva terminates mid-stage trial of Emrusolmin in patients with multiple system atrophy
The oral drug was being evaluated in adults with MSA, a rare and progressive neurodegenerative disorder that affects movement, coordination and balance.
USA – Teva Pharmaceuticals has discontinued its Phase II clinical trial of experimental drug emrusolmin in patients with multiple system atrophy (MSA) after an interim assessment indicated a low probability of meeting the study’s primary endpoint.
The oral drug was being evaluated in adults with MSA, a rare and progressive neurodegenerative disorder that affects movement, coordination and balance.
The condition can also cause muscle stiffness and slow movement, with symptoms worsening as the disease progresses.
Teva said it made the decision following a recommendation from an independent data monitoring committee, which reviewed results from a planned interim analysis to determine whether the trial was likely to achieve its main objective.
The study was designed to assess the safety and efficacy of emrusolmin by measuring changes in patients’ symptom scores over 48 weeks.
Alpha-synuclein remains a therapeutic target
Developed in partnership with Germany-based MODAG GmbH, emrusolmin is an investigational treatment designed to target alpha-synuclein, a protein associated with the development and progression of MSA.
Abnormal accumulation of this protein in nerve cells is a key feature of the disease and has attracted interest from drug developers pursuing treatments for neurodegenerative disorders.
However, developing effective therapies against alpha-synuclein has proved challenging, with several investigational candidates failing to demonstrate clinical benefits.
Leerink Partners analyst Daniel Clark noted that the limited clinical evidence supporting alpha-synuclein-targeting approaches in MSA, alongside previous unsuccessful drug candidates, had tempered expectations for the study.
Teva Chief Medical Officer Eric Hughes said the company was disappointed by the interim assessment but remained committed to examining the available data to understand the findings.
Trial discontinuation does not end development programme
Teva clarified that the decision followed an interim predictive assessment rather than a final analysis of the drug’s efficacy. The company also reported that the review identified no safety concerns.
The distinction leaves open the possibility of further development, as discontinuing the Phase II trial does not constitute a final decision on the broader emrusolmin programme.
The findings will be relevant to Teva and MODAG as they assess the remaining clinical data and determine the next steps for the candidate.
For the wider biopharmaceutical industry, the outcome also highlights the clinical development challenges facing companies pursuing alpha-synuclein as a therapeutic target in MSA, where effective disease-modifying treatments remain an unmet medical need.
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