SPARC concludes enrolment in global Phase 2 study of Vodobatinib in early Parkinson's disease
Vodobatinib is a potential first-in-class, highly selective and brain penetrating c-Abl inhibitor.
Mumbai: Sun Pharma Advanced Research Company Ltd. (SPARC) today announced the completion of enrolment of 506 patients in a global, randomized, doubleblind, placebo-controlled Phase 2 study in patients with early Parkinson's disease evaluating the safety and efficacy of Abl tyrosine kinase inhibition using K0706 (PROSEEK).
"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." said Anil Raghavan, CEO of SPARC.
PROSEEK is global, randomized, double-blind, placebo-controlled Phase 2 study in patients with early Parkinson's disease evaluating the safety and efficacy of Abl tyrosine kinase inhibition using K0706/SCC-138.
The primary endpoint is the change from baseline to week 40 in the score of the MDS-UPDRS Part III (Movement Disorder Society – Unified Parkinson’s Disease Rating Scale).
The key secondary endpoints include:
• Change from baseline to Week 40 in the sum of the MDS-UPDRS Parts II and III total scores
• Time from baseline to initiation of symptomatic medication
• Change in health-related quality of life as measured by the European quality of life questionnaire
• Change in Clinician global impression of severity
Vodobatinib is a potential first-in-class, highly selective and brain penetrating c-Abl inhibitor. Vodobatinib is being evaluated under multiple clinical trials in patients with Parkinson’s disease, Dementia with Lewy Body and Chronic Myelogenous Leukemia.
Read also: Sun Pharma, SPARC collaborate for commercialization of phenobarbital for injection in US
