Articles - Corporate Happenings

Sun Pharma Advanced Research Company Abandons Phase 2 Study on Vodobatinib for Parkinson’s Disease

April 2024

Articles - Corporate Happenings

Sun Pharma Advanced Research Company Abandons Phase 2 Study on Vodobatinib for Parkinson’s Disease

April 2024

Sun Pharma Advanced Research Company Ltd. (SPARC) announced on Wednesday its decision to terminate the Phase 2 study on Vodobatinib for Parkinson’s Disease after the drug failed to demonstrate superiority over placebo, as revealed in the interim analysis.

The decision to discontinue the study stemmed from the findings of the interim analysis conducted during the PROSEEK study, a global, randomized, double-blind, placebo-controlled Phase 2 trial targeting patients with Early Parkinson’s Disease.

In accordance with SPARC's exchange filing, the PROSEEK study compared two dosage regimens of Vodobatinib against a placebo, enrolling a total of 513 patients from the United States, Europe, and India. The interim analysis drew insights from data collected from 442 patients who completed a 40-week treatment regimen in Part I of the study.

In their official statement, SPARC acknowledged that a thorough review of the data concluded that Vodobatinib did not exhibit any evidence of treatment benefit among patients, prompting the decision to halt the study.

While expressing disappointment over the interim analysis results, SPARC emphasized the study's contribution to enhancing the understanding of the role of c-Abl kinase in alpha synucleinopathies. Anil Raghavan, CEO of SPARC, expressed gratitude to all parties involved in the PROSEEK study, including patients, caregivers, researchers, and the dedicated team behind the research efforts.

Moving forward, SPARC intends to undertake a comprehensive analysis of clinical outcomes and correlative biomarker data in the forthcoming months.

financialexpress.com