Phase 2 DIMENSION Study fails to meet primary endpoint
Sage Therapeutics announced that its Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) for cognitive impairment in Huntington’s disease failed to meet its primary and secondary endpoints. Dalzanemdor showed no statistically significant or clinically meaningful improvement versus placebo in the Symbol Digit Modalities Test at Day 84 or in secondary endpoints.
The 12-week, double-blind, placebo-controlled study included 189 participants. Dalzanemdor was well-tolerated, with most adverse events being mild to moderate and no new safety signals observed. However, the lack of efficacy has led Sage Therapeutics to discontinue further development of dalzanemdor.
As a result, the ongoing PURVIEW Study, an open-label safety trial of dalzanemdor, will also be closed. Sage Therapeutics expressed disappointment in the outcome but extended gratitude to participants and researchers involved.
