On Nov 14th in 2022, Roche announced that An Alzheimer’s drug, which has been being developed by Roche, failed to show clear efficacy in slowing disease progression in two Phase 3 clinical trials. It leads to push the rivals Eisai and Biogen.
According to Roche, two Phase 3 trials of Gantenerumab in early Alzheimer’s disease, Graduate 1 and Graduate 2, failed to achieve their primary endpoints. Roche conducted two Phase 3 trials of approximately 1,000 patients with the same design. As a result, compared with placebo, Graduate 1 reduced the worsening of clinical symptoms by 8% and Graduate 2 by 6%, however the difference was not statistically significant.
After this announcement, Roche shares fell 4.4% to a seven-week low. Shares of the rivals Biogen and Eli Lilly jumped 3.8% and 2.3%, respectively. Analysts say that the results of the trial will affect the stock market’s confidence in Roche’s research capabilities. This is actually the second negative news for Roche following the failure of a trial of Tiragolumab, cancer immunotherapy drug, earlier 2022.
Gantenerumab is an antibody drug designed to bind to aggregates of amyloid-beta and clear amyloid plaques from the brain. Amyloid β is believed to play an important role in the development of Alzheimer’s disease.
Roche’s antibody primarily targeted large amyloid structures, whereas Eisai and Biogen’s Lecanemab targets the early stages of amyloid accumulation. Roche announced only the main results of the study on November 14th, with detailed data due to be presented at the Conference on Alzheimer’s Disease Clinical Trials (CTAD) in San Francisco on November 30th. Data from a pivotal late-stage clinical trial of Lilly’s anti-amyloid-beta antibody donanemab are expected to be available by mid-2023.
Source: Roche’s Alzheimer’s drug fails to meet goal in long awaited trial by Reuters
Reference: Roche Alzheimer’s antibody fails to slow cognitive decline in major test by Science
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