Benzinga - by Vandana Singh, Benzinga Editor.
Wednesday, Sage Therapeutics Inc (NASDAQ:SAGE) announced topline results from the PRECEDENT Phase 2 study of dalzanemdor (SAGE-718) in people with mild cognitive impairment in Parkinson’s Disease.
The PRECEDENT Study did not meet its primary endpoint of demonstrating a statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42.
WAIS-IV is the most advanced adult measure of cognitive ability.
Dalzanemdor (SAGE-718) was generally well-tolerated, and no new safety signals were observed.
48 participants experienced treatment-emergent adverse events (TEAEs). The vast majority of TEAES were mild to moderate in severity.
“We are disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease,” said Barry Greene, Chief Executive Officer at Sage Therapeutics.
Analyses did not suggest meaningful differences versus placebo in the other exploratory endpoints, such as SCOPA-Cog, a measure for assessing cognitive function.
Based on the data, the company does not plan to develop dalzanemdor (SAGE-718) further in Parkinson’s Disease.
The company expects the following milestones for the dalzanemdor (SAGE-718) Phase 2 clinical development program in 2024:
- Topline data from the SURVEYOR Study in Huntington’s disease cognitive impairment in mid-2024.
- Topline data from LIGHTWAVE Study in people with mild cognitive impairment and mild dementia in Alzheimer’s disease in late 2024.
- Topline data from the DIMENSION Study in people with Huntington’s disease cognitive impairment in late 2024.
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