UCB has announced “encouraging data” from a phase 2a study of its investigational anti-tau antibody bepranemab in Alzheimer’s disease (AD) patients.
The TOGETHER study has been evaluating the safety, efficacy and tolerability of two dose levels of the drug in patients with prodromal-to-mild cases of the neurodegenerative disorder.
Results presented at this year’s Clinical Trials on AD meeting showed that the primary endpoint of Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), a measure of cognition and function, total score at week 80 was not met.
However, the company highlighted benefits across key secondary endpoints, with bepranemab slowing the rate of tau accumulation versus placebo in key brain regions by 33% to 58% at week 80, and the drug slowed cognitive decline by 21% to 25% versus placebo in the same period.
Improvements also were observed in patients with low tau burden at baseline and APOε4 non-carriers, who represent approximately 50% of the full study population.
A post-hoc analysis of these two predefined subgroups showed that high-dose bepranemab slowed the rate of tau accumulation versus placebo in key brain regions by 63% to 67% at week 80, and slowed clinical disease progression by 29%, as measured by the change in CDR-SB, at week 80.
The subgroup analysis also showed that bepranemab slowed disease progression according to secondary/exploratory endpoints, including measures of Activities of Daily Living by 41% to 54% at week 80.
An estimated 982,000 people are living with dementia in the UK, with AD accounting for up to 75% of cases. The disease slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Bepranemab specifically targets a mid-region epitope of human tau, which is thought to be essential for tau aggregation and is a key driver of neurodegeneration in AD.
UCB’s chief scientific officer, Alistair Henry, said: “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.”
The company said it is now “evaluating next steps” in the bepranemab development programme.