Roche faces setback as crenezumab fails in Alzheimer's study, AC Immune stock slumps 22%

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Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) said its medicine crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer's disease in a study.

The results are a setback for the Swiss drugmaker's pipeline after a new immunotherapy tiragolumab, touted as a potential future blockbuster, failed a second late stage study in lung cancer subtype.

Crenezumab, discovered by AC Immune (NASDAQ:ACIU), was evaluated in the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia trial, according to a June 16 press release.

The company said the study did not show a statistically significant clinical benefit in either of its co-primary goals evaluating the rate of change in cognitive abilities or episodic memory function.

Small numerical differences favoring crenezumab were seen across the co-primary and multiple secondary goal, but these were not statistically significant, Roche added.

The trial enrolled 252 people who are members with ADAD in Colombia, and 94% of them completed the study. About 2/3 of these people carried the Presenilin 1 E280A gene mutation which usually causes cognitive impairment due to Alzheimer’s disease around age 44, said the company.

Participants received either crenezumab or placebo over five to eight years. During the study, crenezumab dose was increased as knowledge about potential treatment approaches for Alzheimer’s disease evolved, Roche noted.

Roche added that within its Alzheimer’s pipeline, it is also evaluating gantenerumab in autosomal dominant Alzheimer's disease, and to prevent sporadic Alzheimer's and treatment of early Alzheimer’s in late stage trials.

Results from phase 3 studies, dubbed GRADUATE, of gantenerumab in early Alzheimer's are expected in Q4 2022.

ACIU -22.03% to $2.23 premarket June 16