Sage Therapeutics- Phase 2 study in Huntington’s Disease meets primary endpoint

Sage Therapeutics announced topline results from the Phase 2 SURVEYOR Study. The study met its primary endpoint demonstrating a statistically significant difference between healthy participants and participants with Huntington’s Disease – HD – prior to any treatment with dalzanemdor or placebo. SURVEYOR was a small study with three objectives: to determine the magnitude of cognitive impairment in HD compared to healthy participants; to evaluate the safety of dalzanemdor in participants with HD; and to better understand the relationship between changes in cognition and changes in function. Dalzanemdor was generally well-tolerated and no new safety signals were observed. A total of 11 participants with HD experienced treatment emergent adverse events, the vast majority of which were mild to moderate in severity. There were no discontinuations related to TEAEs. There was a small numerical difference observed between dalzanemdor and placebo on the HD-CAB composite score at Day 28. Other prespecified analyses suggested the potential for directionally positive signals in a number of individual component tests of the HD-CAB and in some functional assessments. Additional work is ongoing to further analyze and understand the data including the relationship of changes in cognition to changes in function. The company expects dalzanemdor program milestones in late 2024: report topline data from LIGHTWAVE Study in mild cognitive impairment and mild dementia in Alzheimer’s Disease, and report topline data from DIMENSION Study in cognitive impairment associated with HD.