Roche announced its Alzheimer’s drug candidate could not clearly be shown to slow dementia progression in two drug trials, failing to draw level with a recent development success by rivals Eisai and Biogen.
The Switzerland-based drugmaker said in a statement that twin studies named Graduate 1 and 2 had not reached the primary goal of showing that the drug, gantenerumab, could preserve abilities such as solving problems, orientation, remembering, and personal care in patients suffering from early stages of Alzheimer’s disease.
Roche conducted two identically designed studies, each with nearly 1,000 participants, who were examined and queried by physicians over two year period. Within each study, volunteers were randomly allotted to receive either a placebo or the injectable antibody drug gantenerumab.
The medication was associated with a comparative reduction in the clinical decline of 6% in Graduate 2 and 8% in Graduate 1 compared with the placebo, but those outcomes were not statistically reliable, the drugmaker said in a statement.
The setback will be an added challenge for, Thomas Schinecker, Roche’s CEO-designate and its head of diagnostics, who will be promoted in March 2022, replacing CEO Severin Schwan, who led a successful campaign to diversify away from the firm’s traditional focus on cancer.