Sage, Biogen Announce Positive Pivotal Phase 3 Results For Zuranolone - Quick Facts

(RTTNews) - Sage Therapeutics, Inc. (SAGE) and Biogen Inc. (BIIB) announced Tuesday that the WATERFALL Study in patients with Major Depressive Disorder (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.

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 effect.

Zuranolone is an investigational two-week, once-daily oral drug for MDD that represents a potential new class of drug for the management of this common but serious mental health disorder.

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. The study enrolled 543 patients with MDD and they were treated with zuranolone 50 mg or placebo once nightly for 14 days.

The primary endpoint of the study was the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. The first secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Day 15.

Zuranolone was generally well-tolerated in the WATERFALL Study and demonstrated a safety profile consistent with previous clinical studies.

Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration, and the Companies intend to discuss next steps with the Agency.