Roche monoclonal antibody Crenezumab failed again in clinical trials for Alzheimer’s disease
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Roche Aβ monoclonal antibody Crenezumab failed again in clinical trials for Alzheimer’s disease
On June 16, Roche and the Banner Alzheimer’s Institute jointly announced that the Phase II clinical trial of Crenezumabin the Alzheimer’s Prevention Initiative (API) program did not meet the primary study endpoint.
This is a randomized, double-blind, placebo-controlled Phase II trial to evaluate crenezumab in a Colombian subgroup of people with normal cognitive function but an autosomal dominant mutation (ie, at familial risk of Alzheimer’s disease) Potential to slow or prevent Alzheimer’s disease.
A total of 252 subjects were recruited and randomly assigned to receive crenezumab or placebo for 5-8 years. Of these, 94% of the participants completed the study.
The trial showed no statistically significant clinical benefit on the co-primary endpoints of changes in cognitive ability or episodic memory function. These two endpoints were assessed by the Composite Cognitive Score, Free and Selective Cue Cue Test (FCSRT), respectively.
Small, but not statistically significant, differences in favor of crenezumab were observed across multiple secondary and exploratory endpoints.
During the study period, no new safety concerns were identified with crenezumab.
Currently, further analysis of the data is underway. Initial data will be presented at the Alzheimer’s Association International Conference (AAIC) on August 2, 2022.
Crenezumab is a specific monoclonal antibody drug targeting beta-amyloid, suitable for patients with early (prodromal or mild) Alzheimer’s disease.
In 2006, Genentech and AC Immune entered into a co-development agreement for crenezumab.
In 2009, Roche acquired Genentech for $47 billion for the Aβ monoclonal antibody AD drug crenezumab.
In 2014, the phase II study of crenezumab failed, and compared with placebo, it could not significantly delay cognitive and functional decline in patients with mild to moderate Alzheimer’s disease, and did not meet the primary endpoint.
In January 2019, Roche announced the discontinuation of two Phase III CREAD1 and CREAD2 clinical studies of crenezumab in early-stage AD, as first-line results from an interim analysis of an independent data monitoring committee showed that crenezumab may not achieve improvement in patients’ Clinical Dementia Composite Rating Scale scores ( CDR-SB score) primary endpoint.
However, Roche is also conducting a clinical trial of the Aβ monoclonal antibody gantenerumab for Alzheimer’s disease, and the latest phase III study results are expected to be announced in the fourth quarter of 2022.
Roche Aβ monoclonal antibody crenezumab failed again in clinical trials for Alzheimer’s disease
(source:internet, reference only)
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