UCB has announced that results from the Phase 2a TOGETHER study of bepranemab, an investigational anti-tau antibody, have been accepted for presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) Meeting in Madrid, Spain. The study evaluated bepranemab in individuals with prodromal to mild Alzheimer’s Disease (AD).
The TOGETHER study is a Phase 2a, global, multicenter, participant- and investigator-blind, placebo-controlled, parallel-group study. It was designed to investigate the efficacy, safety, and tolerability of two dose levels of bepranemab, administered intravenously every four weeks, compared to placebo. The study population consisted of participants with either prodromal (40%) or mild (60%) Alzheimer’s disease, and the treatment period lasted 80 weeks, followed by a 48-week open-label extension period and a 16-week safety follow-up.
Alistair Henry, Chief Scientific Officer at UCB, stated, “We are pleased to have our innovative research program recognized 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.”
Mechanism of Action
Bepranemab is a recombinant, humanized, full-length immunoglobulin G4 monoclonal antibody (mAb) that specifically targets human tau protein. It targets a central region of tau (amino acids 235–250), near the microtubule binding region (MTBR). The rationale behind this approach is that a mid-region antibody will more potently interfere with cell-to-cell propagation of pathogenic, aggregated tau compared to antibodies targeting other regions of tau.
Regaining Global Rights
UCB also announced that it has regained all global rights to bepranemab following the termination of a Collaboration Agreement with Genentech, a member of the Roche Group, and Roche. UCB had previously entered a worldwide, exclusive license agreement with Roche and Genentech in July 2020 for the global development, manufacturing, and commercialization of bepranemab in Alzheimer’s disease.
The presentation at CTAD will highlight primary and key secondary results from the Phase 2a study, including clinical, safety, and imaging endpoints. The CTAD meeting is a leading forum for the latest developments in clinical trials for Alzheimer’s disease and other dementias, bringing together experts from the pharmaceutical, biotechnology, and medical communities.
