Bepranemab Phase 2a study

Posted on 22 October, 2024 - Alzheimer's Disease, Dementia

Results accepted for Late-Breaking Presentation at Clinical Trials on Alzheimer’s Disease (CTAD) 2024 Meeting

  • Bepranemab – an investigational anti-tau antibody – targeting the mid-region of the tau protein is being studied to assess its potential to delay Alzheimer’s disease progression1 
  • Late-breaking Phase 2a study TOGETHER (AH0003) results include all relevant clinical and imaging data1
  • Late-breaking symposium will take place on 31 October 20242
  • UCB has regained all global rights to bepranemab from Roche/Genentech

22nd October 2024: UCB today announced that the results of its double-blind TOGETHER (AH0003) Phase 2a study of bepranemab – an investigational anti-tau antibody – in people living with prodromal to mild Alzheimer’s Disease (AD), have been accepted for presentation in a late-breaking symposium at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting.2 The CTAD meeting will take place in Madrid, Spain, October 29 – November 1, 2024.

The presentation will highlight primary and key secondary results from the Phase 2a study, including clinical, safety, and imaging endpoints.

“We are pleased to have our innovative research programme recognised by the CTAD committee and look forward to sharing the encouraging results of the TOGETHER study with the scientific community. These new data represent an important step in building a rigorous body of evidence evaluating bepranemab as an investigational treatment option, for people living with early Alzheimer’s disease,” said Alistair Henry, Chief Scientific Officer, UCB.

TOGETHER is a Phase 2a, global, multicenter, participant- and investigator-blind, placebo-controlled, parallel-group study designed to investigate the efficacy, safety and tolerability of bepranemab (two dose levels) – administered intravenously every 4 weeks – versus placebo in participants with prodromal (40% of study population) or mild (60% of study population) Alzheimer’s disease over an 80-week treatment period, followed by a 48-week open-label extension period, and a 16-week safety follow-up period.1

Details of the late-breaking symposium:

  • Title: Results from TOGETHER, a double-blind, placebo-controlled Phase 2 study evaluating efficacy, safety and tolerability of bepranemab in prodromal–mild Alzheimer’s disease
  • Presenters: Martin Citron, PhD (UCB Pharma); Matthew E Barton, PhD (UCB Pharma); Randall J Bateman, MD (Washington University School of Medicine, St Louis, MO, USA)
  • Date/Time: October 31, 5:10pm CET

UCB also announced today that the company has regained all global rights to bepranemab following termination of a Collaboration Agreement with Genentech, a member of the Roche Group, and Roche. In July 2020, UCB entered a worldwide, exclusive license agreement with Roche and Genentech, for the global development, manufacturing, and commercialization of bepranemab in Alzheimer’s disease.3

For more information, visit https://www.ucb.com/clinical-studies/Clinical-Trials?studyId=AH0003

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

About bepranemab

Bepranemab is a recombinant, humanised, full-length immunoglobulin G4 monoclonal antibody (mAb) that specifically targets human tau protein.4,5 Bepranemab targets a central region of tau (amino acids 235–250), near to the microtubule binding region (MTBR). 4,6 The rationale of this approach is that a mid-region antibody will more potently interfere with cell-to-cell propagation of pathogenic, aggregated tau than antibodies that target other regions of tau (ie., the N-terminus).4,6,7

References:

  1. https://www.ucb.com/clinical-studies/Clinical-Trials?studyId=AH0003. Accessed October 2024.
  2. https://www.ctad-alzheimer.com/files/files/PROGRAM_CTAD2024_WEB%20October%2014.pdf. Accessed October 2024.
  3. https://www.ucb.com/stories-media/Press-Releases/article/UCB-enters-into-collaboration-with-Roche-to-develop-antibody-treatment-for-people-living-with-Alzheimer-s-Disease. Accessed October 2024.
  4. Courade JP, et al. Epitope determines efficacy of therapeutic anti-Tau antibodies in a functional assay with human Alzheimer Tau. Acta Neuropathol. 2018;136(5):729–745.
  5. Ewen C, et al. Bepranemab: an overview of the Phase I/IB clinical study program. Presentation at Tau2024, March 25-26, 2024, Washington, D.C, USA.
  6. Albert M, et al. Prevention of tau seeding and propagation by immunotherapy with a central tau epitope antibody. Brain. 2019;142(6):1736–1750.
  7. Alzforum – Networking for a cure. https://www.alzforum.org/therapeutics/bepranemab. Accessed October 2024.