A pair of phase 3 trials studying Roche's Alzheimer's drug candidate in people with early Alzheimer’s failed to hit primary endpoints — dashing hopes of both patients and the drugmaker.
The GRADUATE I and II studies of gantenerumab — a fully-human monoclonal IgG1 antibody — did not significantly slow clinical decline in people with early Alzheimer’s. According to the drugmaker, the level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's disease, was lower than expected.
Like Biogen’s drug aducanumab, gantenerumab targets the beta amyloid protein. Roche had discontinued a phase 3 study for the anti-amyloid medicine back in Dec. 2014 because patients weren't benefiting. A few months later, after seeing the success of Biogen's treatment, Roche announced it planned to re-run its gantenerumab trial — with a higher dose and other adjustments. The GRADUATE higher-dose trials began enrolling in 2018.
Now, it appears as though gantenerumab's journey has come to an end. Roche says it plans to share the results from the GRADUATE trial during the upcoming Clinical Trials on Alzheimer’s Disease Conference on Nov. 30.