Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer ’s disease

Basel, 10 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer ’s disease (AD). This form of AD, known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease.1 The study, sponsored by Washington University School of Medicine in St. Louis, US, did not show a significant slowing of the rate of cognitive decline in people treated with investigational medicine gantenerumab as measured by the novel DIAN Multivariate Cognitive Endpoint, compared with placebo. Overall, gantenerumab's safety profile in DIAN-TU-001 was consistent with that from other clinical trials of the investigational medicine and no new safety issues were identified. Roche is conducting additional analyses to understand the totality of the gantenerumab data from the study, in collaboration with Washington University School of Medicine. Data will be presented at the AAT-AD/PD Focus meeting in April 2020.“We are very grateful to all those involved in this study and hope the data can further contribute to the science and collective understanding of this complex disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Although DIAN-TU di dn’t reach its primary endpoint, the trial represents the first of its kind and a bold...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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