PROSEEK study shows no treatment benefit of Vodobatinib in patients with early Parkinson’s Disease
Both low dose and high dose Vodobatinib arms did not meet the pre-specified primary endpoint of change in MDS-UPDRS Part III total score at week 40 compared to placebo
Sun Pharma Advanced Research Company announced results of interim analysis from the PROSEEK study, a global, randomised, double blind, placebo-controlled Phase 2 study in patients with Early Parkinson’s Disease. PROSEEK compared two doses of Vodobatinib with placebo and enrolled a total of 513 patients from US, Europe and India.
The interim analysis was based on data from 442 patients who completed 40 weeks treatment in Part I of the study. The study failed to demonstrate superiority of Vodobatinib in the prespecified primary endpoint of change in MDS-UPDRS Part III total score as compared to placebo.
SPARC has reviewed the data and determined that the study has not shown evidence of treatment benefit in patients receiving Vodobatinib, and consequently decided to close the study. SPARC plans to complete the full analysis of clinical outcomes and correlative biomarker data in the coming months.
Anil Raghavan, CEO of SPARC commented, “While the interim analysis results were not what we aspired for our patients, the findings from this study will significantly contribute towards expanding the understanding of the role of c-Abl kinase in alpha synucleinopathies.”
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