Benzinga | Jun 15, 2021 07:16AM EDT

Sage Therapeutics - Biogen's Zuranolone Tops Placebo In Reducing Depressive Symptoms

* Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ: BIIB) have announced data from WATERFALL Phase 3 study evaluating zuranolone (SAGE-217/BIIB125) in patients with Major Depressive Disorder (MDD).

* The 543-subject trial met its primary endpoint with zuranolone showing statistically significant improvement in depressive symptoms compared with placebo at Day 15.

* Mean change from baseline depression total score at Day 15 for patients who received zuranolone 50 mg was -14.1 (0.51) compared with -12.3 (0.50) on placebo (LS mean difference -1.7 points).

* Monoamine-based antidepressants have been the standard of care for chronic treatment of MDD for the past 60 years. They are treatments administered daily, which require sufficient exposure and continuous use to maintain the effect.

* Zuranolone is a two-week, once-daily oral drug. It was generally well-tolerated and demonstrated a favorable safety profile.

* The rate of treatment-emergent adverse events (TEAEs) in the zuranolone group was 60.1% vs. 44.6% in placebo. The majority of the TEAEs were mild to moderate.

* The percent of patients reporting TEAEs leading to drug discontinuation was 3.4% and 1.5%, in the zuranolone and placebo groups, respectively.

* No signal for withdrawal symptoms was identified.

* Price Action: SAGE shares are down 14.9% at $62 during the premarket session on the last check Tuesday, while BIIB stock closed at $406.14 on Monday.