Roche says Phase 3 Alzheimer's studies failed to meet primary endpoint - InvestingChannel

Roche says Phase 3 Alzheimer’s studies failed to meet primary endpoint

Roche (RHHBY) announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia, collectively called early Alzheimer’s disease. The studies did not meet their primary endpoint of slowing clinical decline. Gantenerumab was well tolerated, including the subcutaneous administration. Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 and -0.19, respectively, from baseline score on the Clinical Dementia Rating-Sum of Boxes, however, neither was statistically significant. This represents a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo. 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, Roche added. It said, “Roche remains committed to Alzheimer’s disease, one of the most complex neurological disorders and a major public health challenge. The company 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.” Roche was partnering with MorphoSys (MOR) on the GRADUATE I and II studies.

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