Sage Therapeutics Releases Phase 2 DIMENSION Study Results for SAGE-718 in Huntington’s Disease Cognitive Impairment

Sage Therapeutics, Inc. (Nasdaq: SAGE), based in Cambridge, Mass., has released the top-line outcomes from its Phase 2 DIMENSION Study concerning dalzanemdor (SAGE-718) for cognitive impairment linked to Huntington’s Disease (HD). The study, which was a 12-week, double-blind, placebo-controlled trial involving 189 participants, aimed to assess the effects of dalzanemdor.

The primary metric of the study was the score change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84, a measure of cognitive function. Unfortunately, the results indicated that dalzanemdor did not show a statistically significant improvement compared to the placebo at the primary endpoint. Furthermore, secondary endpoint analyses also failed to demonstrate any statistically significant or clinically meaningful differences between the dalzanemdor and placebo groups.

Dalzanemdor was generally well-tolerated, with most treatment-emergent adverse events being mild to moderate in severity. No new safety concerns surfaced during the trial.

Barry Greene, the Chief Executive Officer of Sage Therapeutics, expressed disappointment over the study results, particularly for those affected by Huntington’s Disease who are in dire need of new treatment options. Despite the outcome, he extended his gratitude to the participants, investigators, and the Huntington’s Disease community for their unwavering commitment to the research.

Due to these findings, Sage Therapeutics has decided to halt further development of dalzanemdor. Consequently, they will also be closing the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with Huntington's Disease.

Sage Therapeutics, established in 2010, is a biopharmaceutical firm committed to pioneering solutions for brain health, aiming to deliver transformative medicines. The company has developed two FDA-approved treatments for postpartum depression and continues to advance a pipeline addressing unmet needs in brain health.