Vaccinex provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease. The Company recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease. Following completion of its phase 2 study in HD, the Company recognized that a major market and strategic focus of its potential pharmaceutical partners was AD. The Company, therefore, undertook to determine whether pepinemab had similar effects in AD as it had reported for HD. The SIGNAL-AD clinical trial was a smaller, cost-effective study in AD that focused on common features of disease progression in AD and HD, including an important efficacy endpoint, the well-characterized decline in brain metabolic activity reflected by FDG-PET signal in a key brain region that is affected early in disease. For AD, one such region, identified in multiple prior studies, is the medial temporal cortex from which disease manifestations spread to other temporal regions and, over time, to the rest of the brain. In the randomized SIGNAL-AD study, that goal was clearly reached by data showing a statistically significant difference in FDG-PET signal in the medial temporal cortex following 12-months of treatment with pepinemab compared to placebo. Pepinemab was well-tolerated in AD, consistent with prior clinical experience in HD.
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