Sage Therapeutics (SAGE) presents at 2022 Stifel CNS Days - Slideshow

SAGE-718 Clinical Studies Overview - The DIMENSION study is a Phase 2 placebo-controlled study evaluating SAGE-718 in patients with early Huntington's Disease (HD)[2, 5] - The primary endpoint of the DIMENSION study is the change from baseline in the Composite score of the Huntington's Disease Cognitive Assessment Battery (HD-CAB)[4] - The SURVEYOR study is a Phase 2 placebo-controlled study in patients with early HD, with a Healthy Participant (HP) Comparator Arm[13, 16] - The primary endpoint of the SURVEYOR study is baseline measures of the Huntington's Disease Cognitive Assessment Battery (HD-CAB) cognitive composite score[15] - The PRECEDENT study is a Phase 2 placebo-controlled study in patients with Mild Cognitive Impairment (MCI) due to Parkinson's Disease (PD)[20, 26] - The primary endpoint of the PRECEDENT study is the change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding test[20] Dosing and Study Design - In the DIMENSION study, participants receive either SAGE-718 (1.2 mg oral daily from days 1 to 27; 0.9 mg oral daily from days 28 to 84) or placebo[8, 5] - In the SURVEYOR study, HD participants receive either SAGE-718 (1.2 mg oral daily) or placebo[17, 18] - In the PRECEDENT study, participants receive either SAGE-718 (1.2 mg oral daily) or placebo[24, 22] Inclusion Criteria for HD Studies - Participants in the DIMENSION and SURVEYOR studies must have genetically confirmed HD with huntingtin gene CAG expansion ≥36[6, 18] - Participants in the DIMENSION and SURVEYOR studies must have a UHDRS-Total Functional Capacity (TFC) score >6 and <13[6, 18] - Participants in the DIMENSION and SURVEYOR studies must have a Montreal Cognitive Assessment (MoCA) score <26 at screening[6, 18] Inclusion Criteria for PD-MCI Study - Participants in the PRECEDENT study must be between 50 and 75 years old at screening[23] - Participants in the PRECEDENT study must have a confirmed diagnosis of idiopathic PD according to 2015 MDS clinical diagnostic criteria[23] - Participants meeting Level 1 PD-MCI criteria must have a MoCA score of 20 to 25 (inclusive) at Screening, while those meeting Level 2 PD-MCI criteria must have a MoCA score of 18 to 25 (inclusive) at Screening[23]