Genentech, a member of the Roche Group (RHHBY), said Monday that phase III GRADUATE studies, which evaluated gantenerumab in people with early Alzheimer's disease, did not meet their primary endpoints of slowing clinical decline. Gantenerumab was well tolerated including the subcutaneous administration.
The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's, was lower than expected with gantenerumab treatment, the company said in a statement.
Amyloid-related imaging abnormalities (ARIA) are a common radiological finding associated with amyloid-targeting therapies. The incidence of ARIA-E (edema or effusion) in the pooled gantenerumab arms was 25%, with the vast majority being asymptomatic and very few leading to treatment discontinuation. The incidence of isolated ARIA-H (haemosiderin) was balanced across the gantenerumab and placebo arm.
The company stated hat it is continuing to develop and deliver tests to enable early and accurate Alzheimer's diagnosis and has a pipeline of investigational medicines for different targets, types and stages of the disease.
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