- The stock price of SAGE Therapeutics Inc (NASDAQ: SAGE) fell by over 10% pre-market. This is why it happened.
The stock price of SAGE Therapeutics Inc (NASDAQ: SAGE) fell by over 10% pre-market. Investors responded negatively to the company’s phase 3 results for zuranolone.
Sage Therapeutics and Biogen Inc. (Nasdaq: BIIB) had announced that the WATERFALL Study in patients with MDD met its primary endpoint with zuranolone (SAGE-217/BIIB125) 50 mg showing statistically significant improvement in depressive symptoms compared with placebo at Day 15 as assessed by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. LS means (SE) change from the baseline in HAMD-17 total score at Day 15 for patients who received zuranolone 50 mg was -14.1 (0.51) compared with -12.3 (0.50) for patients who received placebo (LS mean difference -1.7 points; p=0.0141).
The monoamine-based antidepressants have been the standard of care for chronic treatment of MDD over the past 60 years. And they are treatments administered daily, which require sufficient exposure and continuous use to maintain effect.
Zuranolone is a two-week and once-daily oral drug under investigation for the treatment of MDD. And it is a molecule that is designed to potentially provide a rapid-acting, sustainable treatment option, and could represent a breakthrough in the current management of depression.
The WATERFALL Study was a pivotal, Phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years with MDD (N=543). And The WATERFALL Study enrolled patients who had MDD with a HAMD-17 total score ≥24 at screening and Day 1 prior to dosing.
Zuranolone was generally well-tolerated in the WATERFALL Study and demonstrated a safety profile consistent with previous clinical studies. And the rate of treatment emergent adverse events (TEAEs) in the zuranolone group was 60.1% (161/268) vs the placebo group at 44.6% (120/269). The majority of the TEAEs were mild to moderate.
The most common TEAEs that were ≥ 5% in patients treated with zuranolone (rates vs placebo) included somnolence 15.3% (vs 3.0%), dizziness 13.8% (vs 2.2%), headache 10.8% (vs 7.8%), and sedation 7.5% (vs 0.4%). And these events predominantly occurred during the 14-day treatment period.
During the study, a total of 2 patients each (0.7%) reported serious adverse events (SAEs) in the zuranolone and placebo groups and no death occurred in the study. The percent of patients reporting TEAEs leading to drug discontinuation was 3.4% (9/268) and 1.5% (4/269), in the zuranolone and placebo groups, respectively. No signal for withdrawal symptoms as assessed by the 20-item Physician Withdrawal Checklist (PWC-20), or for increased suicidal ideation or behavior as per the Columbia-Suicide Severity Rating Scale (C-SSRS) were identified.
Investors were likely looking for better results than patients with a response at Day 15 to zuranolone retained on average 86% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended).
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
