Sage Therapeutics (NASDAQ:SAGE) announced its Phase 2 SURVEYOR study has met its primary endpoint showing a significant difference in HD-Cognitive Assessment Battery composite scores at baseline between healthy participants and those with Huntington’s disease (HD), highlighting HD’s cognitive impact prior to any treatment with dalzanemdor (SAGE-718) or placebo.
The company reports that SAGE-718 was generally well-tolerated with no new safety signals observed in participants with HD who received SAGE-718 or placebo.
In a statement, Laura Gault, CMO of Sage, said that symptoms of cognitive impairment can precede motor symptoms by up to 15 years and is a historically underrecognized aspect of HD with no approved treatments. “The findings from the SURVEYOR study highlight the extent of cognitive impairment associated with HD and enhance our collective understanding of this devastating disease. This further underscores the importance of developing treatments that can address this critical unmet need for people living with HD.”
Sage is advancing a clinical program for SAGE-718 with multiple, ongoing placebo-controlled Phase 2 studies across disease areas in addition to its potential lead indication, cognitive impairment associated with HD, including mild cognitive impairment and mild dementia in Alzheimer’s disease. Further, the company is conducting an open label safety study in HD cognitive impairment.
