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| 024 | 7 | _ | |a 10.1136/bmjno-2025-001396 |2 doi |
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| 037 | _ | _ | |a DZNE-2026-00253 |
| 041 | _ | _ | |a English |
| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Höglinger, Günter |0 P:(DE-2719)2811373 |b 0 |e First author |u dzne |
| 245 | _ | _ | |a Safety, tolerability and biomarker results of bepranemab in participants with progressive supranuclear palsy: a randomised, multicentre, double-blind, placebo-controlled, phase 1b trial. |
| 260 | _ | _ | |a London |c 2026 |b BMJ Publishing Group |
| 336 | 7 | _ | |a article |2 DRIVER |
| 336 | 7 | _ | |a Output Types/Journal article |2 DataCite |
| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1773045871_14565 |2 PUB:(DE-HGF) |
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| 336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
| 520 | _ | _ | |a 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%; bepranemab n=18, placebo n=7). Seventeen (94.4%) in the bepranemab group reported ≥1 TEAE (five participants; ten investigational medicinal product (IMP)-related TEAEs), versus placebo (n=7; 100%). In the bepranemab and placebo groups, respectively, three participants (16.7%) and one participant (14.3%) discontinued due to TEAEs. Incidence of IMP-related TEAEs and severe TEAEs was similar between groups; no deaths were reported. Reduction (80.41%) in mean free tau cerebrospinal fluid levels was observed in the bepranemab group.Multiple doses of bepranemab 90 mg/kg were well tolerated with an acceptable safety profile in participants with PSP. High target occupancy was observed. |
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| 650 | _ | 7 | |a ALZHEIMER'S DISEASE |2 Other |
| 650 | _ | 7 | |a CLINICAL NEUROLOGY |2 Other |
| 650 | _ | 7 | |a RANDOMISED TRIALS |2 Other |
| 650 | _ | 7 | |a SUPRANUCLEAR PALSY |2 Other |
| 700 | 1 | _ | |a Vandenberghe, Wim |0 0000-0002-9758-5062 |b 1 |
| 700 | 1 | _ | |a Woitalla, Dirk |b 2 |
| 700 | 1 | _ | |a Corvol, Jean-Christophe |b 3 |
| 700 | 1 | _ | |a Van Tricht, Hans |b 4 |
| 700 | 1 | _ | |a Ewen, Colin |b 5 |
| 700 | 1 | _ | |a Van Den Steen, Bart |b 6 |
| 700 | 1 | _ | |a Rebollo Mesa, Irene |b 7 |
| 700 | 1 | _ | |a Germani, Massimiliano |b 8 |
| 700 | 1 | _ | |a Garric, Elodie |b 9 |
| 700 | 1 | _ | |a Arnould, Tasmin |b 10 |
| 700 | 1 | _ | |a Jose, Joby |b 11 |
| 700 | 1 | _ | |a Strong, Nancy |b 12 |
| 700 | 1 | _ | |a De Bruyn, Steven |0 0009-0001-4853-7339 |b 13 |
| 700 | 1 | _ | |a Buchanan, Tim J |0 0000-0003-1218-5420 |b 14 |
| 773 | _ | _ | |a 10.1136/bmjno-2025-001396 |g Vol. 8, no. 1, p. e001396 - |0 PERI:(DE-600)3001578-9 |n 1 |p e001396 |t BMJ neurology open |v 8 |y 2026 |x 2632-6140 |
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