Roche Holding AG said 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 Biogen Inc and Eisai Co.
The Swiss drugmaker said in a statement yesterday that twin studies known as Graduate 1 and 2 had not reached the primary goal of showing that the drug gantenerumab could preserve abilities such as remembering, solving problems, orientation and personal care in patients suffering from early stages of Alzheimer’s disease.
Roche conducted two identically designed studies, each with about 1,000 participants, who were examined and queried by physicians over more than two years. Within each study, volunteers were randomly assigned to receive either the injectable antibody drug gantenerumab or a placebo.
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The drug was associated with a relative reduction in clinical decline of 8 percent in Graduate 1, and 6 percent in Graduate 2, compared with the placebo, but those results were not statistically reliable, the company said in a statement.
Gantenerumab was designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, which are believed to play a crucial role in the slowly progressing dementia disease.
The setback is an added challenge for CEO-designate Thomas Schinecker, Roche’s head of diagnostics, who is to be promoted in March, replacing CEO Severin Schwan, who led a successful campaign to diversify from Roche’s traditional focus on cancer.
Most of the 55 million people suffering from dementia worldwide are believed to be affected by Alzheimer’s disease, according to the WHO.
In 2030, dementia is expected to affect 78 million people. Alzheimer’s is difficult to diagnose, especially during its early stages.
Roche released only the main outcome of the trial yesterday, planning to present detailed data at the Clinical Trials on Alzheimer’s Disease conference in San Francisco on Nov. 30.
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