drugset / Press release

SPARC Announces Results from the Planned Interim Analysis of the PROSEEK Study of Vodobatinib in Patients with Early Parkinson’s Disease • Interim analysis was performed for 442 patients who completed Part I of the PROSEEK study • Both low dose and high dose Vodobatinib arms did not meet the pre -specified primary endpoint of change in MDS -UPDRS Part III total score at week 40 compared to placebo • SPARC has decided to close the ongoing PROSEEK study SPARC to Host Conference Call on April 15, 2024 at 4:30 PM IST

2024-04-15 · Sun Pharma Advanced Research Company Limited · original sparc.life ↗

FOR IMMEDIATE RELEASE SPARC Announces Results from the Planned Interim Analysis of the PROSEEK Study of Vodobatinib in Patients with Early Parkinson’s Disease • Interim analysis was performed for 442 patients who completed Part I of the PROSEEK study • Both low dose and high dose Vodobatinib arms did not meet the pre -specified primary endpoint of change in MDS -UPDRS Part III total score at week 40 compared to placebo • SPARC has decided to close the ongoing PROSEEK study SPARC to Host Conference Call on April 15, 2024 at 4:30 PM IST MUMBAI, April 10, 2024, Sun Pharma Advanced Research Company Ltd. (SPARC) (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872) today announced results of interim analysis from the PROSEEK study, a global, randomised, double blind, placebo-controlled Phase 2 study in patients with Early Parkinson’s Disease. PROSEEK compared two doses of Vodobatinib with placebo and enrolled a total of 513 patients from US, Europe and India. The interim analysis was based on data from 442 patients who completed 40 weeks treatment in Part I of the study. The study failed to demonstrate superiority of Vodobatinib in the pre - specified primary endpoint of change in MDS- UPDRS Part III total score as compared to placebo. SPARC has reviewed the data and determined that the study has not shown evidence of treatment benefit in patients receiving Vodobatinib, and consequently decided to close the study. SPARC plans to complete the full analysis of clinical outcomes and correlative biomarker data in the coming months. Anil Raghavan, CEO of SPARC commented, "While the interim analysis results were not what we aspired for our patients, the findings from this study will significantly contribute towards expanding the understanding of the role of c -Abl kinase in alpha synucleinopathies. Our gratitude extends to all those who played a role in the PROSEEK study, particularly the patients and their caregivers, researchers, and our dedicated team that worked relentlessly on the study.” The Company will host a conference call at 04.30 pm IST on April 15, 2024. This call will be accessible through an audio dial-in. Audio conference Participants can dial-in on the number below: Universal Dial In +91 22 6280 1278 +91 22 7115 8179 India National Toll Free 1800 120 1221 International Toll Free Hong Kong Singapore UK USA 800964448 8001012045 08081011573 18667462133 About PROSEEK: PROSEEK is a global, randomized, double-blind, placebo-controlled Phase 2 study in patients with early Parkinson's disease evaluating the safety and efficacy of c -Abl tyrosine kinase inhibition using Vodobatinib. The primary endpoint of the study was the change from baseline t o week 40 in MDS - UPDRS (Movement Disorder Society – Unified Parkinson’s Disease Rating Scale) Part III total Score. About Vodobatinib (SCC-138/K0706): Vodobatinib is a selective, brain penetrant c-Abl inhibitor, being evaluated in Parkinson’s disease, Lewy Body Dementia and Chronic Myelogenous Leukemia. About SPARC (CIN: L73100GJ2006PLC047837): Sun Pharma Advanced Research Company Ltd. (‘SPARC’) is a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. SPARC consistently aims to lower costs and improve op erational efficiencies to advance availability and affordability of cures for patients across the world. More information about the Company can be found at www.sparc.life. Disclaimer: Statements in this document describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. Media Contact: Jaydeep Issrani Tel +91 22 66455645, Ext: 5787 Tel Direct +91 22 6645 5787 Mobile +91-9820216916 E-mail [email protected] ®, TM - All brand names and trademarks are the property of respective owners.

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