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Roche (OTCQX:RHHBY) (OTCQX:RHHBF) said its medicine gantenerumab did not meet the main goal of slowing clinical decline in two phase 3 studies people with early Alzheimer’s disease.

The results mark a second setback for the Swiss pharma giant in the Alzheimer’s pipeline this year after crenezumab failed a trial called Colombia as the drug did not did not slow or prevent cognitive decline as expected.

On Monday, Roche reported data from the studies GRADUATE 1 and 2, which were evaluating myloid monoclonal antibody gantenerumab, against placebo in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia over 27 months. The study included 1,965 people across 30 countries who received either gantenerumab or placebo by subcutaneous injection.

The company said people treated with gantenerumab showed a slowing of clinical decline of -0.31 in GRADUATE 1 and -0.19 in GRADUATE 2 of -0.31 from baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), but neither was statistically significant.

This represented a relative reduction in clinical decline of 8% in GRADUATE 1 and 6% in GRADUATE 2 compared with placebo, the company added.

The CDR-SB measures cognitive and functional change across six areas including memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.

The level of beta-amyloid removal, the protein which builds up to make plaques in the brains of people with Alzheimer’s, was lower than expected, according to the company.

Roche added that Amyloid related imaging abnormalities (ARIA) are a common radiological finding linked with amyloid-targeting therapies. The incidence of ARIA-E (oedema or effusion – build up of fluid in the body) in the pooled gantenerumab groups was 25%, with the majority being asymptomatic and very few leading to treatment discontinuation.

The company noted that gantenerumab was well tolerated, including the subcutaneous administration.

The results give an edge to Roche’s Alzheimer’s drug rivals Biogen (BIIB) and Eisai (OTCPK:ESALY) (OTCPK:ESALF) whose beta-amyloid targeting drug lecanemab met the main goal of a late-stage study. Lecanemab had cut the cognitive and functional decline of patients with early stage of the disease by 27%, compared to placebo.

In October, even a Roche executive noted that data from the Biogen/Eisai drug bodes well for research based on beta-amyloid targeting Alzheimer’s drugs.

Roche said it will present topline data from the GRADUATE 1 and 2 studies at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Conference on Nov. 30.

BIIB +3.79% to $300.42 premarket Nov. 14


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