Sun Pharma Advanced Research Company has decided to close the study on Vodobatinib, that was being developed to treat early Parkinson’s disease.
The company has reviewed the data from the PROSEEK study and determined that it has not shown evidence of treatment benefit in patients receiving Vodobatinib, and consequently decided to close the study, SPARC told the stock exchange. “SPARC plans to complete the full analysis of clinical outcomes and correlative bio market data in the coming months,” it added.
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Announcing results from the study’s interim analysis – a global, randomised, double blind, placebo-controlled Phase II study in patients with early Parkinson’s disease, it said, PROSEEK compared two doses of Vodobatinib with placebo and enrolled a total of 513 patients from the United States, 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,” it said.
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Anil Raghavan, SPARC chief Executive said, “While the interim analysis results were not what we aspired for our patients, the findings from this study will significantly contribute toward expanding the understanding of the role of c-Abl kinase in alpha synucleinopathies.”
SPARC shares were down nearly 5 per cent, at ₹431.10 on the BSE, at 13.19 pm on Wednesday.