CAMBRIDGE -
The PRECEDENT Study did not meet its primary endpoint of demonstrating 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. Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed.
'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
PRECEDENT Study Results
The PRECEDENT Study was a double-blind, placebo-controlled Phase 2 study in people with MCI in PD. The study is designed to evaluate the safety and efficacy of dalzanemdor (SAGE-718) dosed over 6 weeks. A total of 86 participants were enrolled and randomized.
The PRECEDENT Study did not meet its primary endpoint of demonstrating 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.
Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed. A total of 48 participants experienced treatment emergent adverse events (TEAEs). The vast majority of TEAES were mild to moderate in severity.
Analyses did not suggest any meaningful differences versus placebo in the other exploratory endpoints such as SCOPA-Cog.
Based on the data, the Company does not plan any further development of dalzanemdor (SAGE-718) in PD. The Company expects the following milestones for the dalzanemdor (SAGE-718) Phase 2 clinical development program in 2024
Mid-2024: Report topline data from SURVEYOR Study in people with HD cognitive impairment
Late 2024: Report topline data from LIGHTWAVE Study in people with MCI and mild dementia in AD
Report topline data from DIMENSION Study in people with HD cognitive impairment
About dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718), a first-in-class investigational NMDA receptor positive allosteric modulator (PAM), is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, including Huntington's disease (HD) and Alzheimer's disease (AD). Sage is advancing a clinical program for dalzanemdor (SAGE-718) with multiple ongoing placebo-controlled Phase 2 studies across multiple disease areas, including its potential lead indication, cognitive impairment associated with HD, as well as cognitive impairment in AD. The Company is also conducting an open-label safety study in HD cognitive impairment.
About
Forward-Looking Statements
Various statements in this release concern future expectations, plans and prospects, including without limitation statements regarding: our expectations with respect to the timing of reporting of results from ongoing clinical trials of dalzanemdor; our belief in the unmet need for new treatment options for brain health disorders; the potential for positive results from ongoing studies of dalzanemdor in HD and AD, despite negative results from the PRECEDENT study in PD; our views regarding possible distinctions among indications as a result of the underlying pathophysiology and symptomatology in PD; our statements as to the potential for dalzanemdor in the treatment of cognitive impairment due to certain neurodegenerative diseases and the mission, goals, opportunity and potential for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. Sage explicitly disclaims any obligation to update any forward-looking statements.
Contact:
Tel: +1 917 930 7147
Email: Matthew.Henson@sagerx.com
Tel: +1 786 252 1419
Email: Ashley.Kaplowitz@sagerx.com
(C) 2024 Electronic News Publishing, source