TY  - JOUR
AU  - Höglinger, Günter
AU  - Vandenberghe, Wim
AU  - Woitalla, Dirk
AU  - Corvol, Jean-Christophe
AU  - Van Tricht, Hans
AU  - Ewen, Colin
AU  - Van Den Steen, Bart
AU  - Rebollo Mesa, Irene
AU  - Germani, Massimiliano
AU  - Garric, Elodie
AU  - Arnould, Tasmin
AU  - Jose, Joby
AU  - Strong, Nancy
AU  - De Bruyn, Steven
AU  - Buchanan, Tim J
TI  - Safety, tolerability and biomarker results of bepranemab in participants with progressive supranuclear palsy: a randomised, multicentre, double-blind, placebo-controlled, phase 1b trial.
JO  - BMJ neurology open
VL  - 8
IS  - 1
SN  - 2632-6140
CY  - London
PB  - BMJ Publishing Group
M1  - DZNE-2026-00253
SP  - e001396
PY  - 2026
AB  - 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
KW  - ALZHEIMER'S DISEASE (Other)
KW  - CLINICAL NEUROLOGY (Other)
KW  - RANDOMISED TRIALS (Other)
KW  - SUPRANUCLEAR PALSY (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:41789119
C2  - pmc:PMC12958890
DO  - DOI:10.1136/bmjno-2025-001396
UR  - https://pub.dzne.de/record/285476
ER  -