Sage Therapeutics reports results from Phase 2 DIMENSION Study

Sage Therapeutics (SAGE) announced topline results from the Phase 2 DIMENSION Study of dalzanemdor, or SAGE-718, in participants with cognitive impairment, or CI, associated with Huntington’s Disease, or HD. In the study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test, or SDMT, at Day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor. The DIMENSION Study was a 12-week, double-blind, placebo-controlled Phase 2 study to evaluate the effects of dalzanemdor in participants with CI associated with HD. A total of 189 participants were randomized. The DIMENSION Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the SDMT, a measure of cognitive function, at Day 84, the primary endpoint. Dalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment emergent adverse events were mild to moderate in severity. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences between the dalzanemdor and placebo treatment groups. Given these findings, the Company also will close the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.