Sage Therapeutics(US:SAGE)2022-03-01 14:10Zuranolone Clinical Development and Potential - Zuranolone, a GABA PAM, shows potential to reshape the depression landscape with rapid improvement in depressive symptoms [33, 41] - Clinical data supports zuranolone's potential to fulfill unmet needs for people with MDD and PPD, offering rapid response, short course treatment, and a favorable tolerability profile [28, 30] - The CORAL study demonstrated that zuranolone 50 mg co-initiated with an ADT resulted in a statistically significant improvement in HAMD-17 total score CFB at Day 3 (p=0004) [53] - In the SHORELINE study, approximately 80% of patients using zuranolone 30 mg and approximately 70% of patients using zuranolone 50 mg who responded to the initial treatment course received 1 or 2 treatment courses [47] - Integrated analyses of SF-36 patient-reported outcomes data showed approximately 40-60% improvement in mental health domains and approximately 8-12% improvement in physical and general health domains with zuranolone [85] - The most common TEAEs across zuranolone studies were headache (6-18%), somnolence (7-16%), and dizziness (6-15%) [99] Sage Therapeutics Portfolio and Financials - Sage has a leading brain health portfolio with expertise in brain circuitry and a rich pipeline across 3 franchises [16] - Sage's product platform aims to launch a new product or indication every 12-24 months starting in 2023 [16] - Sage has over $17 billion in capital/collaborations to fund efforts to accelerate and advance medicines [16] - Sage estimates a potential to impact over 450 million patients globally [16]