Sun Pharma Announces Results of Interim Analysis From PROSEEK Study

Sun Pharma Advanced Research Company Ltd. (SPARC) recently disclosed the results of an interim analysis from the PROSEEK study on April 10, 2024. This global Phase 2 clinical trial investigated the efficacy and safety of Vodobatinib, a potential treatment for patients in the early stages of Parkinson’s Disease.

PROSEEK Study Design

The PROSEEK study was designed as a randomised, double-blind, and placebo-controlled trial, and it involved 513 patients across the United States, Europe, and India. Participants were randomly assigned to receive either Vodobatinib at two different dosage levels or a placebo. The primary objective of the study was to assess the effectiveness of Vodobatinib compared to placebo in improving motor function, as measured by the change in scores on the MDS-UPDRS Part III scale (Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III).

Interim Analysis Results

The interim analysis was conducted after 442 patients completed 40 weeks of treatment in the first part (Part I) of the PROSEEK study. The analysis did not demonstrate a statistically significant difference in the pre-specified primary endpoint (change in MDS-UPDRS Part III score) between the Vodobatinib groups and the placebo group. In simpler terms, the initial data suggests that Vodobatinib was not superior to placebo in improving motor function in these patients with early Parkinson’s Disease.

“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,” said Anil Raghavan, CEO of SPARC.

Moving Forward

Based on these interim findings, SPARC made the decision to terminate the PROSEEK study. While this is undoubtedly a setback, SPARC intends to complete a comprehensive analysis of all clinical data collected during the trial. This analysis will encompass not only the primary endpoint but also secondary outcome measures and any potential correlations between treatment response and specific biomarkers. The full analysis is expected to be finalised in the coming months.

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