Dalzanemdor fails to meet endpoints in phase 2 study of patients with Huntington’s disease

A phase 2 clinical trial of dalzanemdor in those with cognitive impairment associated with Huntington’s disease failed to meet its primary and secondary endpoints, causing the manufacturer to halt development of the investigational therapy.

DIMENSION was a 12-week, double-blind, placebo-controlled study that enrolled 189 individuals with cognitive impairment associated with Huntington’s.

Dalzanemdor (SAGE-718, Sage Therapeutics) failed to demonstrate a statistically significant difference compared with placebo in change from baseline on the Symbol Digit Modalities Test at day 84. Results also showed no significant difference in participants treated with dalzanemdor compared with those given placebo, Sage Therapeutics said in a release.

Dalzanemdor was generally well-tolerated with no new safety signals reported, and most recorded treatment-emergent adverse events were mild to moderate in severity, according to the release.

In light of the DIMENSION study findings, Sage said it will also halt the ongoing PURVIEW clinical trial, an open-label safety of dalzanemdor in participants with Huntington’s.

“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,” Sage Therapeutics CEO Barry Greene said in the release. “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.”