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Shares of Sage Therapeutics, which specializes in neurodegenerative diseases, fall after disappointing Parkinson's data
Wednesday.Sage Therapeutics, Inc.(NASDAQ Resonance: SAGE) announced preliminary results from the PRECEDENT Phase 2 study of dalzanemdor (SAGE-718) for the treatment of patients with mild cognitive impairment in Parkinson's disease.
The PRECEDENT study did not reach its primary endpoint of a statistically significant difference from baseline on the Wechsler Adult Intelligence Scale, Fourth Edition-IV (WAIS-IV) coded test scores for patients treated with once-daily dalzanemdor versus those treated with placebo at Day 42.
The WAIS-IV is the most advanced measure of adult cognitive ability.
The total tolerability of Dalzanemdor (SAGE-718) was good and no new safety signals were identified.
Treatment-emergent adverse events (TEAEs) occurred in 48 participants. The vast majority of TEAEs were mild to moderate in severity.
"We are disappointed with the results of the PRECEDENT Phase 2 study given the tremendous burden that mild cognitive impairment places on Parkinson's patients and their families," said Barry Greene, Chief Executive Officer of Sage Therapeutics, Inc.
At other exploratory endpoints (e.g., the SCOPA-Cog, an indicator of cognitive functioning) the analysis showed no significant differences compared to placebo.
Based on these data, the Company does not intend to further develop dalzanemdor (SAGE-718) in the Parkinson's disease space.
The Company expects the dalzanemdor (SAGE-718) Phase 2 clinical development project to reach the following milestones in 2024:
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First-line data from the mid-2024 Huntington Cognitive Disorder SURVEYOR study.
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First-line data from the LIGHTWAVE study in patients with mild cognitive impairment and mild dementia in Alzheimer's disease, late 2024.
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First-line data from the DIMENSION study of patients with cognitive dysfunction in Huntington's disease, late 2024.
Price Trend:Shares of SAGE stock traded down 23.80% on Wednesday, hitting $11.91.
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This article, "Sage Therapeutics Shares Focused on Neurodegenerative Diseases Fall on Disappointing Parkinson's Disease Data" originally appeared on Benzinga.com.
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