Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
- Dam, Tien;
- Boxer, Adam L;
- Golbe, Lawrence I;
- Höglinger, Günter U;
- Morris, Huw R;
- Litvan, Irene;
- Lang, Anthony E;
- Corvol, Jean-Christophe;
- Aiba, Ikuko;
- Grundman, Michael;
- Yang, Lili;
- Tidemann-Miller, Beth;
- Kupferman, Joseph;
- Harper, Kristine;
- Kamisoglu, Kubra;
- Wald, Michael J;
- Graham, Danielle L;
- Gedney, Liz;
- O'Gorman, John;
- Haeberlein, Samantha Budd;
- PASSPORT Study Group
- et al.
Published Web Location
https://pubmed.ncbi.nlm.nih.gov/34385707/Abstract
A randomized, double-blind, placebo-controlled, 52-week study (no. NCT03068468) evaluated gosuranemab, an anti-tau monoclonal antibody, in the treatment of progressive supranuclear palsy (PSP). In total, 486 participants dosed were assigned to either gosuranemab (n = 321) or placebo (n = 165). Efficacy was not demonstrated on adjusted mean change of PSP Rating Scale score at week 52 between gosuranemab and placebo (10.4 versus 10.6, P = 0.85, primary endpoint), or at secondary endpoints, resulting in discontinuation of the open-label, long-term extension. Unbound N-terminal tau in cerebrospinal fluid decreased by 98% with gosuranemab and increased by 11% with placebo (P < 0.0001). Incidences of adverse events and deaths were similar between groups. This well-powered study suggests that N-terminal tau neutralization does not translate into clinical efficacy.
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