UCB shares promising data for Alzheimer's candidate bepranemab

UCB has revealed promising data from a phase 2a clinical trial of its experimental anti-tau antibody, bepranemab, aimed at treating Alzheimer's disease (AD). The TOGETHER study has been investigating the safety, efficacy, and tolerability of two dosage levels of bepranemab in patients with early-stage Alzheimer's, specifically those with prodromal to mild cases of the neurodegenerative illness.

During a presentation at the Clinical Trials on Alzheimer's Disease (CTAD) meeting, the primary endpoint was discussed. This endpoint, measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) which assesses cognition and function, was not achieved at week 80 of the study. Despite this, UCB underscored the positive outcomes seen in several secondary endpoints. Notably, bepranemab reduced the rate of tau accumulation in critical brain regions by 33% to 58% compared to a placebo over the 80-week period. Additionally, the drug showed a reduction in cognitive decline by 21% to 25% relative to the placebo.

Patients who had a low tau burden at the start of the study and those who were non-carriers of the APOε4 gene—making up approximately half of the study's participants—also saw improvements. A post-hoc analysis of these predefined subgroups indicated that high-dose bepranemab reduced tau build-up in important brain regions by 63% to 67% compared to the placebo after 80 weeks. Furthermore, the treatment slowed the clinical progression of the disease by 29%, as measured by changes in the CDR-SB at the same time point.

The subgroup analysis also demonstrated that bepranemab could decelerate disease progression according to other secondary and exploratory measures, including assessments of Activities of Daily Living (ADL). These measures showed improvements of 41% to 54% at week 80.

In the UK, around 982,000 individuals are estimated to be living with dementia, with Alzheimer's disease responsible for up to 75% of these cases. Alzheimer's gradually erodes memory, cognitive abilities, and eventually, the capability to perform basic tasks.

Bepranemab is designed to target a specific mid-region epitope of human tau protein. This region is believed to be crucial for tau aggregation, a process that contributes significantly to neurodegeneration in Alzheimer's disease.

Alistair Henry, UCB’s chief scientific officer, expressed optimism about the findings. "We are deeply encouraged by the proof-of-concept data for bepranemab, which highlight its potential to impact early AD progression. This strengthens our belief in the value of targeting the mid-region of tau as an important strategy in altering the trajectory of the disease," he stated.

Moving forward, UCB has indicated that it is in the process of determining the "next steps" in the development of bepranemab. The positive data from the phase 2a trial provides a promising outlook for the future of this investigational treatment in altering the course of Alzheimer's disease, and further research and development efforts are anticipated.