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The TAURIEL Phase II study evaluating semorinemab in early AD did not meet its primary efficacy endpoint

Wednesday 23 September 2020

On 23 September, the Swiss-based biopharmaceutical company AC Immune announced that its partner Genentech, a member of the Roche group, has reported top line results from a Phase II clinical trial of semorinemab, an anti-tau monoclonal antibody, in early Alzheimer’s disease (AD). The Phase II TAURIEL study is a 73-week, double-blind and placebo-controlled trial evaluating the efficacy and safety of semorinemab in people with prodromal to mild AD. A total of 457 participants across 97 study centers in Canada, Europe and US received one of three intravenous doses of semorinemab or placebo.

Top line results showed that the safety endpoint was met. However, the study did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating scale Sum of Boxes (CDR-SB) scores compared to placebo. In addition, two secondary endpoints were also not met (ADAS-Cog13 and ADCS-ADL). Genentech is continuing to analyse data and plans to present the results at an upcoming conference.