Top-line data from Lauriet Phase 2 trial of semorinemab in mild-to-moderate AD shows a statistically significant reduction on one of two co-primary endpoints, ADAS-Cog11
First evidence of clinical activity in tau-targeting monoclonal antibody in MMSE 16-21 (mild-to-moderate) AD population
Semorinemab demonstrated a statistically significant reduction in cognitive decline from baseline by 43.6% compared to placebo (p<0.0025) as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item Version (ADAS-Cog11) at week 49 in people with mild-to-moderate AD (i.e., Mini-Mental State Examination (MMSE) 16-21). There was no effect on the other co-primary endpoint of reducing the rate of functional decline from baseline as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) or secondary efficacy endpoints for the Mini-Mental State Examination (MMSE) or the Clinical Dementia Rating-Sum of Boxes (CDR-SB). The safety was consistent with previous clinical data reported.
About the Lauriet study
Lauriet is a double-blind, placebo-controlled, randomized Phase II trial assessing semorinemab, an investigational anti-tau monoclonal antibody, compared to placebo in 272 adult participants with mild-to-moderate AD across 43 study centers globally. The primary endpoints of the study evaluated the change from baseline at week 49 in cognition as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11) and the change from baseline in activities of daily living as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. Secondary endpoints evaluated cognitive and functional measures including changes from baseline as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE). The Lauriet open label extension is ongoing. For more information, visit ClinicalTrials.gov (NCT03828747).
Semorinemab is an investigational monoclonal anti-tau antibody that targets the N-terminal portion of the tau protein, and is designed to bind to tau and slow its spread between neurons. In tauopathies such as AD, tau misfolds and forms tangles, which cause cell damage and ultimately neuronal death. It is hypothesized that abnormal tau protein then spreads between neurons, gradually involving more areas of the brain, and leading to clinical disease progression. Tau-targeting antibody therapies are designed to slow or stop this process of tau spread. Semorinemab is being developed by
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