Teva 因无效性分析将终止 emrusolmin 治疗多系统萎缩的 II 期试验

The review met the predefined futility criterion, suggesting a low probability of demonstrating efficacy.

Teva Pharmaceuticals has announced plans to halt a Phase II clinical trial evaluating emrusolmin (TEV-‘286) to treat adults with multiple system atrophy (MSA), after an interim analysis found the study was unlikely to meet its primary efficacy endpoint.

The decision followed a recommendation from the independent data monitoring committee (IDMC), which conducted a prespecified interim futility analysis of the TOPAS-MSA study.

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IDMC’s review met the predefined futility criterion, suggesting a low probability of demonstrating efficacy if the trial continued.

Teva noted this was a predictive assessment rather than a final efficacy analysis. No safety concerns arose from the interim review.

An investigational, orally administered small molecule, emrusolmin targets alpha-synuclein aggregation, a core pathogenic mechanism expected to be involved in MSA, a rare neurodegenerative disorder. Teva is developing the therapy in collaboration with MODAG.

The randomised, double-blind, placebo-controlled TOPAS-MSA trial is designed to enrol nearly 350 participants.

They were to receive either 300mg of emrusolmin or placebo for roughly 48 weeks, followed by a follow-up period of four weeks.

The primary endpoint measured change from baseline to week 48 in the modified Unified Multiple System Atrophy Rating Scale Part I score.

Teva global R&D executive vice-president and chief medical officer Eric Hughes said: “While we are disappointed by the outcome of this interim analysis for the Phase II study, we remain deeply committed to learning everything we can from these data.

“We are deeply grateful to the patients, families, investigators, and study teams who contributed their time and commitment to this research. Our hope is that the science and learnings can deepen our understanding of MSA and help us determine a path forward for emrusolmin.”

Teva said it would work with study investigators to ensure protocols are followed as the trial ends. The company also plans to share the findings with the scientific community after concluding a comprehensive analysis.

It said that the discontinuation applies only to the TOPAS-MSA study and does not represent a final decision on the emrusolmin programme as a whole.

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