Sage Therapeutics, Inc. (SAGE) has announced disappointing news for its Alzheimer’s disease drug candidate, dalzanemdor (SAGE-718). The company has decided to halt further clinical development of the drug after the Phase 2 LIGHTWAVE study failed to demonstrate a significant improvement in cognitive function in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease (AD).
The LIGHTWAVE study, which involved 174 participants, assessed the effects of dalzanemdor compared to placebo using the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test as the primary outcome measure. The results, however, showed no statistically significant difference between the two groups at Day 84.
This setback adds to a string of recent disappointments for Sage Therapeutics. Earlier this year, the company’s PRECEDENT Phase 2 study of dalzanemdor in people with mild cognitive impairment in Parkinson’s Disease also failed to meet its primary endpoint. In September, Biogen Inc (BIIB) terminated its collaboration agreement with Sage for the SAGE-324 program, a drug candidate for the chronic treatment of essential tremor (ET). This decision followed negative results from the Phase 2 KINETIC 2 Study of SAGE-324, leading to the discontinuation of further clinical development in ET.
Despite these setbacks, Sage Therapeutics remains optimistic about the future of dalzanemdor. The company plans 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. The drug was generally well-tolerated in clinical trials, with no new safety signals observed.
This news has had a significant impact on SAGE stock, which was down 11.30% at $5.96 during the premarket session on Tuesday.
The pursuit of effective treatments for Alzheimer’s disease is a complex and challenging endeavor. While this recent setback is disappointing for Sage Therapeutics, it highlights the need for continued research and development in this critical area.
