Terrence Fisher, PhD, Vaccinex Inc., Rochester, NY, provides insights into the ongoing Phase I/II SIGNAL-AD study (NCT04381468) of pepinemab, a SEMA4D blocking antibody. This study focuses on assessing the safety and tolerability of pepinemab in early Alzheimer’s disease (AD) patients. The trial recruited 50 participants who underwent IV infusions every 4 weeks for 44 weeks, with a 1:1 randomization to 40mg/kg pepinemab or placebo. The study specifically recruited patients with mild dementia due to AD, requiring a mini-mental state examination (MMSE) score between 17-26. Key study outcomes include safety, tolerability, clinical measures and crucially, changes in biomarkers like FDG-PET, GFAP, and other soluble biomarkers. As of now, there are no safety concerns, and the release of topline data is anticipated in the fall of 2024. This interview took place at the Clinical Trials on Alzheimer’s Disease (CTAD) congress 2023 in Boston.
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