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Thursday, June 16, 2022

Roche provides update on Alzheimer’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease

Roche provides update on Alzheimer’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease

· Crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease

· For more than a decade Roche has been working in collaboration with Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging on this pioneering prevention study

· Initial data will be presented at the upcoming Alzheimer's Association International Conference

Basel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimer’s Institute, today announced results from the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial. The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer’s disease. The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively.

Small numerical differences favouring crenezumab were observed across the co-primary and multiple secondary and exploratory endpoints, but these were not statistically significant. No new safety issues were identified with crenezumab during the study. Further analyses of data are ongoing. Initial data will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022.

“We’re disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said Eric M. Reiman, M.D., Banner Alzheimer’s Institute executive director and one of the study leaders. “At the same time, we’re proud of the impact that this precedent-setting trial has had in shaping a new era in Alzheimer’s prevention research and we’re extremely grateful to our research participants and their families. This trial, the data, samples and findings that we’ll share with the research community, and the related work that we and others are doing promise to further accelerate the evaluation and approval of future prevention therapies.”

The trial enrolled 252 people who are members of the world’s largest extended family with ADAD in Colombia, with 94% of participants completing the study. Two-thirds of participants carried the Presenilin 1 E280A mutation which typically causes cognitive impairment due to Alzheimer’s disease around age 44. Participants were randomised to receive crenezumab, an investigational treatment discovered by AC Immune SA, or placebo over five to eight years. During the trial, the dose of crenezumab was increased as knowledge about potential treatment approaches for Alzheimer’s disease evolved.

“While this is a disappointing result, we would like to thank the participants and their families - they have made an enormous contribution to advancing both understanding and the search for new treatments for familial Alzheimer's disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We remain committed to contributing further scientific evidence to advance how Alzheimer’s disease is understood, diagnosed and treated.”

The study, which was supported by the National Institute on Aging, generous philanthropic contributions to Banner Alzheimer’s Foundation, and Roche, has generated a wealth of data that will advance the early detection, tracking and study of Alzheimer’s disease and inform the design of future Alzheimer’s prevention trials.

Within its Alzheimer’s pipeline, Roche is also evaluating the potential of gantenerumab in autosomal dominant Alzheimer’s disease, as well as for the prevention of sporadic Alzheimer’s and treatment of early Alzheimer’s in late stage clinical trials. Results from the phase III GRADUATE studies of gantenerumab in early Alzheimer’s are expected in Q4, 2022.

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