- Source : Press Release
- Date : 2021-06-22
- Event type : Phase 3
- Companies : Roche
Roche Gantenerumab Improves Biomarkers in Inherited Form of Alzheimer's Disease
A new study, published in Nature Medicine, has showed that Roche's investigational candidate gantenerumab led to improvements in a number of biomarkers in patients with an inherited form of Alzheimer's disease.
In the DIAN-TU-001 trial, researchers from the Dominantly Inherited Alzheimer Network-Trials Unit (DIAN-TU) evaluated two investigational anti-amyloid antibodies – gantenerumab or Lilly's solanezumab – versus placebo in patients with dominantly inherited Alzheimer's disease (DIAD).
The study was conducted over a period of seven years, with patients followed from December 2012 to November 2019, with an average follow-up of five years.
Among patients with DIAD, gantenerumab led to a significant reduction in amyloid plaques and also reduced cerebrospinal fluid (CSF) total tau and phosphorylated-tau181 (p-tau181) levels compared to placebo.
However, the trial did not show evidence of cognitive benefit among patients with this rare, early-onset form of Alzheimer's, although the trial itself was not designed to measure the cognitive impact of the drug on people who started treatment prior to developing symptoms.
The patients included in the study were at numerous stages of asymptomatic and symptomatic disease, said the researchers.
In addition, researchers found that although both drugs engaged amyloid-beta targets, solanezumab showed no benefit on the tau and NfL biomarkers.
In contrast, gantenerumab reduced CSF total tau and p-tau181 compared to placebo at year four.
In 2020, Lilly's solanezumab was unable to show benefit for patients with DIAD, while another arm of the study testing Roche's gantenerumab also ended in failure in DIAD.
At the time, despite the disappointing results, analysis of gantenerumab continued in the DIAN-TU-001 trial, led by researchers from the Washington University School of Medicine.
Following the biomarkers results, researchers from the DIAN-TU will conduct an exploratory open-label extension study of gantenerumab, to continue to monitor the drug's effect on patients' symptoms over time.
In addition, two phase 3 trials of gantenerumab – named GRADUATE 1 and GRADUATE 2 – are currently also ongoing in people with early sporadic Alzheimer's disease.
The recent US Food and Drug Administration (FDA) approval of Biogen's Aduhelm for Alzheimer's disease has renewed hopes for the anti-amyloid field, although the decision to approve the drug has been met with criticism.