Biogen announced in its annual results and earnings presentation that its Phase II SPARK study of cinpanemab (BIIB054), under development for Parkinson’s disease, missed its primary and secondary endpoints. Based on this data, the company has decided to discontinue further development of cinpanemab.
SPARK was a multicenter, randomized, double-blind, placebo-controlled study, with an active-treatment dose-blinded period, and enrolled approximately 350 patients with Parkinson’s disease. The primary endpoint was the change from baseline in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 and Week 72. Secondary endpoints included safety assessments and changes in the individual components of MDS-UPDRS, as well as comparisons among MDS-UPDRS scores at different time points.
Cinpanemab is a human-derived antibody that targets alpha-synuclein, thought to be one of the key hallmarks of Parkinson’s disease. In the brains of people with Parkinson’s disease, there often are protein clumps predominantly composed of alpha-synuclein; these clumps, typically referred to as “aggregates,” are thought to drive disease progression. By targeting these protein clumps, researchers had hoped cinpanemab would stop the spread of protein aggregates in the brain, thus slowing disease progression.