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.
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.”
Read also: SPARC announces retirement of Dr Chitturi Trinadha Rao - Senior Vice President, Drug Discovery
Sun Pharma Advanced Research Company Limited (SPARC) is a clinical-stage biopharmaceutical company. SPARC was formed in 2007 after a demerger from Sun Pharmaceutical Industries Limited. At SPARC, therapeutic focus is in the area of oncology, neurodegeneration and immunology, three critical fields that pose significant challenges in healthcare.
SPARC is a dynamic innovation community with a geographic presence in two countries – US and India, and offices situated in 3 locations of Mumbai, Vadodara and Princeton. Its research facility at Vadodara is spread over 46000 sq.ft. with 42 labs housing 200+ scientists.
Read also: SPARC announces retirement of Dr Chitturi Trinadha Rao - Senior Vice President, Drug Discovery
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