Sage Therapeutics announced that dalzanemdor (SAGE-718) failed to perform in the Phase 2 DIMENSION Study of cognitive impairment (CI) associated with Huntington’s Disease (HD), a rare neurological disorder.
The DIMENSION study failed to meet its primary endpoint. The experimental drug showed no significant improvement over placebo in the primary endpoint, which measured the change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84.
Secondary endpoints also showed no statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to those who were given placebo.
Based on these findings, Massachusetts-based Sage Therapeutics has announced it will not pursue further development of dalzanemdor.
Earlier this year, the asset failed to meet key goals in Alzheimer’s and Parkinson’s studies, leading the Nasdaq-listed biotechnology company to halt its development for those conditions as well.
In July, Biogen and Sage Therapeutics stopped further studies for their neurological disorder drug, SAGE-324, after it failed in a mid-stage trial.
Sage Therapeutics CEO Barry Greene said: “We are disappointed by the results of the DIMENSION Study, especially for the individuals and families affected by Huntington’s Disease who have long awaited new treatment options.
“Innovation is desperately needed, and we are immensely grateful to the participants, investigators, and the entire Huntington’s Disease community whose unwavering commitment to advancing research helped make this study possible.”
The DIMENSION study was a 12-week, double-blind, placebo-controlled Phase 2 trial designed to assess the effects of dalzanemdor. A total of 189 participants were randomized to receive either SAGE-718 or placebo.
However, dalzanemdor was generally well-tolerated, with no new safety concerns.
Based on these results, the biotechnology company will also terminate the separate ongoing PURVIEW Study, an open-label safety trial of dalzanemdor in Huntington’s disease participants.
Sage Therapeutics plans to evaluate options for its early-stage drug candidates and focus on Zurzuvae, its postpartum depression treatment developed with Biogen.
Last month, the company announced the departure of its finance chief and plans to lay off over 165 employees as it focuses on the launch of Zurzuvae.
The biotechnology firm has two US Food and Drug Administration (FDA)-approved treatments for postpartum depression and is advancing a pipeline focused on addressing unmet needs in brain health.
