Sun Pharma Advanced Research Company halts Parkinson's disease drug trial

Mumbai: Sun Pharma Advanced Research Company Ltd. (SPARC) today 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.

Read also: SPARC concludes enrolment in global Phase 2 study of Vodobatinib in early Parkinson's disease

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.

Vodobatinib is a selective, brain penetrant c-Abl inhibitor, being evaluated in Parkinson’s disease, Lewy Body Dementia and Chronic Myelogenous Leukemia.

Read also: SPARC enters into an exclusive worldwide license agreement with Johns Hopkins University, IOCB for hair loss drug

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. Our gratitude extends to all those who played a role in the PROSEEK study, particularly the patients and their caregivers, researchers, and our dedicated team that worked relentlessly on the study.”