On 10 November, the clinical-stage biopharmaceutical company AC Immune presented the full topline data from its Phase II trial LAURIET of semorinemab in mild-to-moderate Alzheimer’s disease (AD) during a late-breaking session at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Conference.
Lauriet is a double-blind, placebo-controlled and randomised Phase II trial assessing semorinemab, an investigational anti-Tau monoclonal antibody, in participants with mild-to-moderate AD. The company recently announced top-line results of a prespecified population consisted of 204 participants who had missed <1 dose of study drug. Results showed that the trial met one of its two co-primary endpoints by demonstrating a statistically significant reduction in cognitive decline of 43.6% in participants receiving semorinemab compared to placebo at week 49, as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item Version (ADAS-Cog11). 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).
The data presented at CTAD showed that the top-line results were confirmed in the larger population including all 241 participants who had received >1 dose of study drug. A significant reduction in cognitive decline of 42.2% was observed with semorinemab compared to placebo, as measured by ADAS-Cog11. No significant treatment effect was observed on the other co-primary endpoint or the secondary endpoints.Biomarker analyses showed that an increase of plasma Tau levels with semorinemab treatment. There was not effect on global or reginal Tau distribution as assessed by positron emission tomography (PET) scans. Further analyses evaluating the effect of semorinemab on cerebrospinal fluid (CSF) biomarkers are ongoing. In addition, safety data from the trial confirmed that semorinemab is well tolerated.
