Roche's partner AC Immune said Tuesday that the former has decided to initiate a second Phase III study of the experimental Alzheimer's disease therapy crenezumab. AC Immune noted that the CREAD2 trial will enrol 750 patients with prodromal or mild Alzheimer's disease.
Roche is currently conducting the Phase III CREAD1 study, investigating the anti-Abeta antibody in 750 people with prodromal or mild Alzheimer's disease, with results expected to read out in 2020. AC Immune CEO Andrea Pfeifer remarked "we remain confident about the potential of crenezumab given it is distinct from other beta amyloid antibodies, predominantly blocking oligomers in the brain."
According to AC Immune, the decision by Roche was supported by data the company presented last year at the Clinical Trials on Alzheimer's disease Conference (CTAD) to support the "unique" binding and increased dosing of crenezumab. AC Immune added that Roche has developed a model that predicts, relative to Phase II trials, an improved outcome of the late-stage study in patients with prodromal-to-mild Alzheimer's disease by using the higher dose of the drug.
Crenezumab was discovered by AC Immune and out-licensed to Roche's Genentech unit in 2006.
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