Sun Pharma Advanced Research Company Ltd. (SPARC) on Wednesday announced that it is abandoning the Phase 2 study on Vodobatinib for Parkinson’s Disease. According to the company’s exchange filing, the study “failed to demonstrate superiority of Vodobatinib” as compared to placebo.
The decision was based on the 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.
According to the company’s statement, PROSEEK compared two doses of Vodobatinib with a placebo and enrolled a total of 513 patients from the US, Europe and India. The interim analysis was based on data from 442 patients who completed 40 weeks of treatment in Part I of the study.
“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,” the company stated in its exchange filing on Wednesday.
SPARC plans to complete the full analysis of clinical outcomes and correlative biomarker data in the coming months, it added.
“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,” Anil Raghavan, CEO of SPARC said in a statement.
On Wednesday, shares of SPARC slumps 5 percent during intraday trade.
