Mumbai-based pharmaceutical company, Sun Pharma Advanced Research Company Ltd. (SPARC), said it was abandoning its Phase 2 study on Vodobatinib for Parkinson's.
The study was designed to evaluate the safety and efficacy of the selective c-Abl tyrosine kinase inhibitor in patients with early Parkinson's disease.
The PROSEEK study was a global trial that enrolled 513 patients with early Parkinson's disease from the United States, Europe, and India. The primary endpoint of the study was an improvement in the symptoms, as measured by Movement Disorder Society – Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III.
However, the interim analysis, based on data from 442 patients who completed 40 weeks of treatment, failed to demonstrate the superiority of Vodobatinib compared to placebo in the primary endpoint. As a result, SPARC has decided to close the PROSEEK study, the company said.
Parkinson's disease is a progressive neurodegenerative disorder that affects movement, causing tremors, stiffness, and difficulty with balance and coordination. It is caused by the loss of dopamine-producing brain cells, and current treatments focus on managing symptoms rather than slowing or stopping the progression of the disease.
SPARC, a subsidiary of Sun Pharmaceutical Industries Ltd., is focused on developing innovative therapeutics and delivery systems to improve patient care globally. The company had high hopes for Vodobatinib as a potential disease-modifying treatment for Parkinson's disease.
Despite the disappointing results, the company said the findings from this study will contribute to expanding the understanding of the role of c-Abl kinase in alpha synucleinopathies, a group of neurodegenerative disorders characterized by the accumulation of alpha-synuclein protein in the brain, including Parkinson's disease.
SPARC plans to complete a full analysis of the clinical outcomes and correlative biomarker data from the PROSEEK study in the coming months. The company will host a conference call on April 15, 2024, to discuss the results and their implications for future research in this area.