• Source : Press Release
  • Date : 2021-07-23
  • Event type : Phase 3
  • Companies : Roche

Roche Engaged in Talks With FDA for Alzheimer's Drug Candidate


Roche is engaged in talks with the US Food and Drug Administration (FDA) for its investigational Alzheimer's disease drug candidate gantenerumab, according to the company's chief executive officer.

CEO Severin Schwan told reporters on Thursday that Roche is in “a continued dialogue with the FDA. I wouldn't be able to speculate what the outcome of this dialogue will be”.

He also revealed that Roche is planning to complete a phase 3 trial of the drug in the second half of 2022, adding that the “trial is a well-designed, very comprehensive trial so, whatever the outcome of this trial will be, we will have a definitive answer of what we can do for patients with this terrible disease so let's keep fingers crossed”.

In June, a study published in Nature Medicine showed that 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).

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.

Gantenerumab was also found to reduce CSF total tau and p-tau181 compared to placebo at year four.

Following the biomarkers results, researchers from the DIAN-TU are set to 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.