By Sneha S K
Nov 2 (Reuters) – Teva Pharmaceuticals said on Monday it was discontinuing its mid-stage neurodegenerative disorder study due to a low probability of the study meeting its main goal if continued.
The company was testing its experimental oral drug, emrusolmin, in adults with multiple system atrophy, a rare neurodegenerative disorder that causes people to lose coordination and balance or become slow and stiff.
The drugmaker said the decision was based on the recommendation of an independent data monitoring committee based on a planned early analysis to assess whether the study was unlikely to succeed.
The trial was testing the efficacy and safety of emrusolmin, designed to target a key disease mechanism called alpha-synuclein in multiple system atrophy. The study’s main goal was to measure changes in patients’ symptom scores over 48 weeks.
“Limited clinical evidence and history of unsuccessful candidates targeting alpha-synuclein aggregation in MSA kept our expectations for (the study) measured,” said Leerink Partners analyst Daniel Clark.
“While we are disappointed by the outcome of this interim analysis for the Phase 2 study, we remain deeply committed to learning everything we can from these data,” said Eric Hughes, chief medical officer at Teva.
This was an interim predictive assessment and not the study’s final efficacy analysis. No safety concerns were identified in the interim analysis, Teva said.
The drug is being developed in partnership with MODAG GmbH, and the trial discontinuation does not represent a final decision on the broader emrusolmin program, Teva said.
Teva plans to share the study findings after completing its comprehensive analysis.
(Reporting by Sneha S K in Bengaluru; Editing by Anil D’Silva and Shreya Biswas)
