%0 Journal Article
%A Höglinger, Günter
%A Vandenberghe, Wim
%A Woitalla, Dirk
%A Corvol, Jean-Christophe
%A Van Tricht, Hans
%A Ewen, Colin
%A Van Den Steen, Bart
%A Rebollo Mesa, Irene
%A Germani, Massimiliano
%A Garric, Elodie
%A Arnould, Tasmin
%A Jose, Joby
%A Strong, Nancy
%A De Bruyn, Steven
%A Buchanan, Tim J
%T Safety, tolerability and biomarker results of bepranemab in participants with progressive supranuclear palsy: a randomised, multicentre, double-blind, placebo-controlled, phase 1b trial.
%J BMJ neurology open
%V 8
%N 1
%@ 2632-6140
%C London
%I BMJ Publishing Group
%M DZNE-2026-00253
%P e001396
%D 2026
%X Preclinical evidence suggests targeting the mid-region of tau as a viable therapeutic strategy in diseases such as progressive supranuclear palsy (PSP): a rare, fatal, neurodegenerative tauopathy with no currently approved treatments. Bepranemab is a recombinant, humanised, full-length immunoglobulin G4 monoclonal antibody binding to a mid-region tau epitope. We assessed safety, tolerability and pharmacokinetics of bepranemab in participants with PSP.PSP003 (NCT04185415), a multicentre, double-blind, placebo-controlled, phase 1b study, recruited participants in hospital settings across 13 centres. Participants (aged ≥40 years) met Movement Disorder Society-PSP criteria for possible/probable PSP, could walk ≥5 steps with minimal/no assistance and were stable on treatment for ≥2 weeks prior to baseline. Participants were randomised 3:1 to receive intravenous bepranemab (90 mg/kg) or placebo every 4 weeks for 52 weeks. Primary endpoint: incidence of treatment-emergent adverse events (TEAEs) from baseline to last visit.Twenty-five participants were enrolled (male: 44
%K ALZHEIMER'S DISEASE (Other)
%K CLINICAL NEUROLOGY (Other)
%K RANDOMISED TRIALS (Other)
%K SUPRANUCLEAR PALSY (Other)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:41789119
%2 pmc:PMC12958890
%R 10.1136/bmjno-2025-001396
%U https://pub.dzne.de/record/285476