VCNX - Vaccinex's lead candidate misses primary endpoints in mid-stage HD study
Vaccinex (VCNX) has reported topline results from the early manifest treatment arm (Cohort B1, N=179) of the Phase 2 SIGNAL trial of its lead candidate, pepinemab, in patients with early manifest and prodromal Huntington’s disease ((HD)). The study had two co-primary endpoints, a family of two cognitive assessments and Clinical Global Impression of Change ((CGIC)).Although the study did not meet pre-specified co-primary endpoints, the results of each of the two cognitive assessments demonstrated a strong trend for beneficial change, reflecting changes in planning ability and memory associated with disease progression.Similarly, a trend of benefit in CGIC did not show a statistically significant difference between the placebo and pepinemab-treated groups, possibly due to small group size in the study.Pepinemab was well-tolerated with remarkably low treatment discontinuation and study drop-out rates over the extended 18 month treatment period.Additional results including a broader examination of motor activity and outcomes for a smaller group of 86
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Vaccinex's lead candidate misses primary endpoints in mid-stage HD study