Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial

Publication date: June 2019Source: The Lancet Neurology, Volume 18, Issue 6Author(s): Adam L Boxer, Irfan Qureshi, Michael Ahlijanian, Michael Grundman, Lawrence I Golbe, Irene Litvan, Lawrence S Honig, Paul Tuite, Nikolaus R McFarland, Padraig O'Suilleabhain, Tao Xie, Giridhar S Tirucherai, Clifford Bechtold, Yvette Bordelon, David S Geldmacher, Murray Grossman, Stuart Isaacson, Theresa Zesiewicz, Tina Olsson, Kumar Kandadi MuralidharanSummaryBackgroundProgressive supranuclear palsy is a rare neurodegenerative disease associated with dysfunctional tau protein. BIIB092 is a humanised monoclonal antibody that binds to N-terminal tau and is thus being assessed as a potential novel treatment for progressive supranuclear palsy. We aimed to investigate the safety and tolerability of BIIB092 in individuals with progressive supranuclear palsy.MethodsThis 12-week, double-blind, randomised, placebo-controlled, multiple ascending dose, phase 1b trial was done at 13 outpatient sites in the USA. Participants aged 41–86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled. Three BIIB092 dose escalation cohorts (150 mg, 700 mg, or 2100 mg; eight participants per cohort) were tested sequentially. For each dose cohort, the first two participants were randomly assigned by a computer-generated scheme to receive either BIIB092 or placebo intravenously every 4 weeks for 57 days. After 2 days, the ...
Source: The Lancet Neurology - Category: Neurology Source Type: research