Sage Therapeutics Faces Setback

Shares of Sage Therapeutics fell by 25% in premarket trading following disappointing topline results from its Phase 2 LIGHTWAVE study of dalzanemdor (SAGE-718) for mild cognitive impairment (MCI) and mild dementia related to Alzheimer's disease (AD).

The trial failed to meet its primary endpoint, showing no statistically significant difference between dalzanemdor and placebo.

About the LIGHTWAVE Study

The LIGHTWAVE study was a 12-week, randomized, double-blind, placebo-controlled trial designed to evaluate cognitive function improvements using the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test.

Results indicated no meaningful cognitive improvements in participants treated with dalzanemdor compared to those receiving placebo. Exploratory measures like the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA) also showed no significant benefits.

Future Directions

Following the findings, Sage Therapeutics announced it would discontinue clinical development of dalzanemdor for Alzheimer's disease. However, the company remains focused on ongoing research, with results from the Phase 2 DIMENSION study—targeting cognitive impairment related to Huntington's disease—expected later this year.

Barry Greene, CEO of Sage Therapeutics, expressed gratitude towards participants, investigators, care partners, patient advocates, and the Alzheimer's community, stating, "While we are disappointed by the results of the LIGHTWAVE Study, we are grateful for the support that made this research possible. We hope our work helps inform future studies."

Despite this setback, the company noted that dalzanemdor was generally well-tolerated, with no new safety issues reported from the study.