Sage Therapeutics’ dalzanemdor did not meet primary endpoint in Phase 2 study

Sage Therapeutics announced today topline results from LIGHTWAVE, a 12-week, Phase 2 placebo-controlled study to evaluate the effects of dalzanemdor 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 Coding Test score at Day 84, the primary outcome measure of the study. Based on these data, the company does not plan further clinical development of dalzanemdor in AD. The company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington’s Disease later this year. 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. Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as RBANS total score or MoCA total score.