On Nov. 14, Roche Pharmaceuticals (Roche) said in a news release on its website that the company’s gantenerumab monoclonal antibody developed for the treatment of patients with mild cognitive impairment (MCI) caused by early Alzheimer’s disease did not achieve a slowing effect on cognitive decline and failed in a phase 3 clinical trial.
gantenerumab is a fully human IgG1 monoclonal antibody.
It targets and binds aggregated forms of beta-amyloid, including oligomers, protofibrils and plaque forms, by subcutaneous administration and activates immune cells in the brain to clear amyloid plaques.
The trial included two double-blind, randomized, placebo-controlled clinical trials.
The data showed only an 8% and 6% relative reduction in cognitive decline in participants receiving gantenerumab injections in the 2 trial arms compared to placebo, and lower than expected levels of clearance of beta-amyloid by the antibody.
Previously, the key pathogenic mechanism of beta-amyloid in Alzheimer’s disease had been questioned.
According to the Science (Science) website, the failure of the gantenerumab trial may make the academic community wary of antibodies against beta-amyloid, such as the aducanumab antibody drug that has been approved for marketing in 2021.
Some scientists are now awaiting the results of a trial of another anti-β-amyloid antibody, donanemab, developed by Eli Lilly and Company, which is now nearing the end of its phase 3 trial.