Investing.com -- Sage Therapeutics shares fell as much as 25% in premarket trading after the company announced disappointing topline results from its Phase 2 LIGHTWAVE study of dalzanemdor (SAGE-718) for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD).
The trial failed to meet its primary endpoint, showing no statistically significant difference between dalzanemdor and placebo.
The LIGHTWAVE study, a 12-week, randomized, double-blind, placebo-controlled trial, aimed to assess improvements in cognitive function using the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test.
However, the company said the results showed no meaningful improvements in participants treated with dalzanemdor compared to those on placebo.
Additionally, exploratory endpoints, including the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA), also failed to demonstrate significant benefits.
Following the findings, Sage Therapeutics announced it will no longer pursue clinical development of dalzanemdor for Alzheimer's disease.
The company, however, remains committed to ongoing research, with results from the Phase 2 DIMENSION study, focusing on cognitive impairment related to Huntington's disease, expected later this year.
"While we are disappointed by the results of the LIGHTWAVE Study, we are grateful to participants, investigators, care partners, patient advocates and the Alzheimer's community who helped make this important research possible. We hope our work and these findings help to inform future research," said Barry Greene, CEO of Sage Therapeutics.
Despite the setback, Sage highlighted that dalzanemdor was generally well-tolerated, with no new safety concerns arising from the study.