Sun Pharma Advanced Research Company (SPARC) on Monday announced the successful completion of enrollment for 506 patients in a global Phase 2 study aimed at investigating the safety and efficacy of Abl tyrosine kinase inhibition using PROSEEK in early Parkinson's disease.
PROSEEK, one of the largest phase-2 studies in early Parkinson's disease, encompassed 84 sites across the United States, Europe, and India. This achievement represents a major leap forward in the quest for treatments and therapies for this debilitating neurological disorder.
PROSEEK is a global, randomised, double-blind, placebo-controlled Phase 2 study focusing on patients with early Parkinson's disease. The study's primary objective is to evaluate the safety and efficacy of Abl tyrosine kinase inhibition using Vodobatinib and PROSEEK.
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Anil Raghavan, CEO of SPARC, stated, "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."
Vodobatinib is a highly selective and brain-penetrating c-Abl inhibitor. It is currently under evaluation in multiple clinical trials for patients with Parkinson's disease, Dementia with Lewy Body, and Chronic Myelogenous Leukemia. c-Abl is a protein that plays a role in various cellular processes, including cell growth, differentiation, and apoptosis.
The focus of the study's evaluation is to assess the change in the MDS-UPDRS Part III score (Movement Disorder Society – Unified Parkinson's Disease Rating Scale) from the baseline to week 40 It also evaluates the change in the sum of MDS-UPDRS Parts II and III total scores from baseline to week 40.