On Wednesday, Sage Therapeutics Inc (NASDAQ:SAGE) revealed topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington's Disease (HD), an inherited brain disorder that causes nerve cells in the brain to break down and die.
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 (SDMT) at Day 84.
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SDMT is used for cognitive evaluation, and measures sustained attention, processing speed, visual scanning, and motor speed.
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 to develop dalzanemdor further.
"We are disappointed by the results of the DIMENSION Study," said Barry Greene, Chief Executive Officer of Sage Therapeutics.
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.
Given these findings, the company will also close the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.
In October, Sage Therapeutics released topline results from the Phase 2 LIGHTWAVE study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD).
The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the study's primary outcome measure.
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This article After Failed Alzheimer's Study, Sage Therapeutics' Dalzanemdor Flunks Another Study In Patients With Inherited Brain Disorder originally appeared on Benzinga.com