SPARC achieves enrollment goal in PROSEEK Phase 2 Parkinson’s trial

Sun Pharma Advanced Research Company Ltd. (SPARC) has announced the successful completion of patient enrollment for the PROSEEK study, a significant global Phase 2 clinical trial focusing on early Parkinson’s disease. This large-scale study has successfully enrolled 506 patients across 84 sites in the United States, Europe, and India, positioning it among the most extensive Phase 2 studies in this field.

Exploring a Potential Treatment for Parkinson’s Disease

PROSEEK, a randomized, double-blind, placebo-controlled study, aims to evaluate the safety and efficacy of Vodobatinib (K0706/SCC-138), an innovative Abl tyrosine kinase inhibitor, in patients with early Parkinson’s disease. The primary goal of the study is to observe changes from baseline to week 40 in the MDS-UPDRS Part III score (Movement Disorder Society – Unified Parkinson’s Disease Rating Scale), a crucial measure in Parkinson’s research.

Investigating Comprehensive Endpoints

Beyond the primary focus, key secondary endpoints of the PROSEEK study include changes in the MDS-UPDRS Parts II and III total scores, the time from baseline to the initiation of symptomatic medication, variations in health-related quality of life as measured by the European quality of life questionnaire, and changes in Clinician’s global impression of severity. These comprehensive measurements are critical to understanding the broader impacts of the treatment.

CEO’s Acknowledgment

SPARC CEO Anil Raghavan expressed his gratitude towards all involved in the study: “This is a significant milestone for SPARC & Vodobatinib. I would like to express my gratitude to all the patients, caregivers, and the physicians associated with PROSEEK.”

The completion of enrollment for the PROSEEK study is a pivotal development in the ongoing research and treatment of Parkinson’s disease. With Vodobatinib being a potentially first-in-class, highly selective, and brain-penetrating c-Abl inhibitor, this study marks an important step forward in exploring new treatments for patients with early stages of Parkinson’s, Dementia with Lewy Bodies, and Chronic Myelogenous Leukemia.