SPARC concludes enrolment in global Phase 2 study of Vodobatinib in early Parkinson's disease

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.

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