Vaccinex reports data for SIGNAL-AD Phase 1b/2 trial of pepinemab

Vaccinex announced positive results of its early stage SIGNAL-AD clinical trial of pepinemab antibody in AD. Topline results were presented by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial, at the Alzheimer’s Association International Conference in Philadelphia. The clinical trial met its designated primary endpoint of safety by indicating that pepinemab is well-tolerated by patients with AD. No Serious Treatment Emergent Adverse Events Related to Treatment were reported by investigators at any of the 16 clinical sites that participated in this study. The only TEAE leading to discontinuation in the entire trial was in the placebo group. Vaccinex had previously reported that pepinemab was well-tolerated by patients with Huntington’s disease and multiple sclerosis. An important secondary endpoint of the study was to determine whether pepinemab prevents decline in brain metabolic activity consistent with blocking astrocyte reactivity as evidenced by an increase in FDG-PET imaging signal in a major brain region known to be affected by disease progression. This was determined over the course of 12-months treatment with pepinemab relative to placebo. We report that pepinemab treatment resulted in a statistically significant increase in FDG-PET signal in the medial temporal cortex of patients with Mild Cognitive Impairment due to AD.