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AC Immune announces top-line results from LAURIET, their Phase 2 trial of semorinemab

Tuesday 31 August 2021

On 31 August, AC Immune announced the first top-line results from LAURIET, their Phase 2 trial of semorinemab, showing an improvement in cognitive decline but no effect on functional decline for participants with mild-to-moderate Alzheimer's disease.

Semorinemab is a monoclonal anti-tau antibody that was co-developed by AC Immune and Genentech, part of the Roche group. LAURIET is a placebo-controlled Phase 2 study of semorinemab that started recruiting participants with mild-to-moderate Alzheimer's disease (AD) in January 2019, with study centers based in the US, France, Poland and Spain. Semorinemab is delivered as an intravenous infusion every 2-4 weeks, and the two primary endpoints in LAURIET are changes in cognitive function as measured by ADAS-Cog11 (Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-item version), and changes in activities of daily living as measured by ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living).

In their announcement, AC Immune stated that participants with mild-moderate AD who received semorinemab during the year-long, double-blind period of the trial had a significant reduction in cognitive decline of 43.6% compared to participants receiving the placebo.  There was no effect on the co-primary endpoint of functional decline, or on the secondary efficacy endpoints on the MMSE (Mini-Mental State Examination) or CDR-SB scales (Clinical Dementia Rating - Sum of Boxes).

Further analyses and top-line data will be presented at the CTAD conference in November. The open-label extension part of the LAURIET study is still ongoing.