Baseline Characteristics of Participants of the SPARK Trial, a Phase 2 Study of the anti-alpha-synuclein antibody Cinpanemab (BIIB054) in Parkinson's Disease

Objective: To describe baseline characteristics of the participants with Parkinson’s Disease (PD) enrolled in the ongoing SPARK (NCT03318523) phase 2 study. Background: Aggregated alpha-synuclein (α-syn), a major constituent of Lewy bodies, is thought to play a central role in the progression of PD. Cinpanemab (BIIB054), a monoclonal antibody that preferentially binds to aggregated forms of α-syn, is in development as a potential treatment for PD. Design/Methods: Baseline characteristics of participants enrolled in the SPARK trial, an ongoing phase 2, randomized, double-blind, placebo-controlled, adaptively designed, parallel group study to evaluate safety of Cinpanemab for PD, were analyzed. The study enrolled untreated participants aged 40–80 years, diagnosed with PD within 3 years and who had SPECT imaging with DaTscanTM showing evidence of striatal dopaminergic deficit. Participants were randomized to treatment with Cinpanemab or placebo, administered intravenously every 4 weeks. Results: Enrollment began in January 2018, at 85 sites in 9 countries, and has been completed. Baseline data were summarized for 357 participants (mean [SD] age, 60.1 [9.02] years). The majority of participants are male (70.0%), and most are Caucasian (90.8%). Median time since disease onset at enrollment was 1.4 years, and median time since diagnosis was 0.5 years. Baseline mean (SD) Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) total score was 32.2 (12.61). Additional baseline characteristics including Modified Schwab and England ADL scale, Physical Activity Scale for the Elderly (PASE), and cognitive function, as measured by the Montreal Cognitive Assessment (MoCA), will be presented. Conclusions: The SPARK trial participants exhibit disease characteristics at baseline typical for early PD and provide contemporaneous information on early PD clinical trial recruitment. Trial recruitment was completed ahead of projected timelines, confirming the feasibility of rapid enrollment of de novo patients with PD. Disclosure: Dr. Fox has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities as an employee of Biogen. Dr. Siderowf has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory board: Biogen, Axovant. Data and Safety Monitoring Board: Prilenia Therapeutics, Prevail Therapeutics, Wave Life Sciences.. Dr. Siderowf has received research support from Site investigator: Voyager Therapeutics, Denali Therapeutics.. Dr. Fernandez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant/Speaker: Ipsen, Merz Pharmaceuticals, Pfizer, Teva Neuroscience, Zambon Pharmaceuticals; CME Speaker: Advanced Health Media, Cleveland Clinic CME, Medical Communications Media, Movement Disorders Society, Vindico MedicalEducation. Dr. Fernandez has received personal compensation in an editorial capacity for Co-Medical Editor: the Movement Disorders Society Website. Dr. Fernandez has received royalty, license fees, or contractual rights payments from Demos Publishing, Manson LTD. Dr. Fernandez has received research support from Abbott Laboratories, Acadia Pharmaceuticals, Biotie Therapeutics, EMD-Serono, Huntington Study Group, Merck, Michael J. Fox Foundation, Movement Disorders Society, National Parkinson Foundation, NIH/NINDS, Novartis, Parkinson Study Group, Synosia, Teva Ph. Dr. Tanner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Voyager Therapeutics, Intec Pharma, Neurocrine Biosciences, Adamas Therapeutics, Grey Matter, CNS Ratings, Acorda, Amneal. Dr. Tanner has received research support from BioElectron, Roche/Genentech, Biogen Idec , Gateway LLC.Dr. Postuma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant: Roche, Biogen, Theranexus, GE HealthCare, Jazz Pharmaceuticals, AbbVie, Jannsen, Otsuka, PhotoPharmics, Inception Sciences, Curasen. Dr. Postuma has received research support from Research Support: Roche. Dr. Simon has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant: Biogen. Dr. Simon holds stock and/or stock options in Spouse owns stock in Biogen. Dr. Simon has received research support from Clinical trial grant: BioElectron Technology. Dr. Byrne has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with SPARK: Biogen. Dr. Lang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant: AbbVie, Acorda, AFFiRis, Biogen, Janssen, Lilly, Lundbeck, Merck, Paladin, Roche, Seelos, Syneos, Sun Pharma, Theravance. Dr. Lang has received royalty, license fees, or contractual rights payments from Elsevier, Saunders, Wiley-Blackwell, Johns Hopkins Press, Cambridge University Press.Dr. Brooks has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant: Biogen, GE Healthcare. Dr. Rascol has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting/advisory board: AbbVie, Adamas, Acorda Therapeutics, Addex Therapeutics, AlzProtect, Apopharma, AstraZeneca, Axovant Gene Therapies, Bial, Biogen, Britannia Industries, Bukwang Pharmaceutical, Cerespir, Clevexel Pharma, Denali Therapeutics, Lun. Dr. Rascol has received research support from Grant: Agence Nationale de la Recherche (ANR), CHU de Toulouse, France-Parkinson, INSERM-DHOS Recherche Clinique Translationnelle, MJFox Foundation, Programme Hospitalier de Recherche Clinique, European Commission (FP7, H2020). Dr. Tolosa has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant: Teva Pharmaceutical Industries, Bial, Boehringer Ingelheim, UCB, Solvay, Lundbeck, Biogen. Dr. Tolosa has received research support from Spanish Network for Research on Neurodegenerative Disorders (CIBERNED)- Instituto Carlos III (ISCIII), The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Dr. Poewe has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultancy fee/lecture fee: AbbVie, Affiris, Bial, Biogen, Britannia Industries, Intec Pharma, Lundbeck, Denali Therapeutics, Merz, NeuroDerm, Neurocrine Biosciences, Novartis, Orion Pharma, Roche, Prexton Therapeutics, Teva Pharmaceutical Industries, .Dr. Stocchi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant, Speaker, Advisory Board: Chiesi Farmaceutici, EMD Serono, GlaxoSmithKline, IMPAX Laboratories, Lundbeck, Novartis, Merck Sharpe & Dohme, UCB, Sunovion Pharmaceuticals, and Teva Pharmaceutical Industries, Biogen, Kyowa Kirin. Dr. Stocchi has received research support from Chiesi Farmaceutici, EMD Serono, GlaxoSmithKline, IMPAX Laboratories, Lundbeck, Novartis, Merck Sharpe & Dohme, UCB, Sunovion Pharmaceuticals, and Teva Pharmaceutical Industries, Biogen, Kyowa Kirin. Dr. Mollenhauer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche, Biogen, UCB and Sun Pharma Advanced research Company.Dr. Giladi has nothing to disclose. Dr. Hirschhorn has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Cedarbaum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Cedarbaum has received personal compensation in an editorial capacity for Biogen. Dr. Cedarbaum has received compensation for serving on the Board of Directors of Biogen. Dr. Nomikos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Former employee of Biogen and current employee of Scholar Rock. Dr. Fanning has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employees of and hold stock/stock options in Biogen. Dr. Fanning holds stock and/or stock options in Biogen, stock greater than 10K which sponsored research in which Dr. Fanning was involved as an investigator. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee: Biogen. Dr. Xiao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Brys has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee: Biogen.