Sage Therapeutics, Inc. ( SAGE Quick Quote SAGE - Free Report) and partner Biogen ( BIIB Quick Quote BIIB - Free Report) announced top-line data from the phase III study — WATERFALL — evaluating oral depression candidate, zuranolone (SAGE-217/BIIB125). The study met its primary endpoint by achieving statistically significant and clinically meaningful reduction in depressive symptoms in patients with major depressive disorder (“MDD”). However, investor sentiments were dampened likely due to concerns related to sustenance of response and failure to meet statistical significance for secondary endpoint.
Please note that zuranolone works by targeting receptors of a neurotransmitter known as GABA, helping to restore the normal balance in the brain.
Shares of Sage declined 19.3% on Jun 15 following the study data readout. In fact, the company’s shares have lost 32% so far this year compared with the
industry’s decrease of 7.7%. Image Source: Zacks Investment Research
Data from the WATERFALL study showed that once every night treatment for two weeks with 50mg of zuranolone improved patients' scores by almost 51% on average from baseline on the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common method for measuring depression severity. The placebo-adjusted improvement was 1.7 points on the HAMD-17 score. Moreover, data also showed onset of response as early as day 3 following treatment. However, HAMD-17 scores reduced over the course of treatment. Patients treated with the candidate retained on average 86.1% of their HAMD-17 improvement after four weeks of completion of 14-day treatment regimen.
Meanwhile, the candidate failed to meet statistical significance on the Clinical Global Impression-Severity of Illness scale, the study’s secondary endpoint, at day 15.
We remind investors that another phase III study — MOUNTAIN — evaluating 30mg of zuranolone in MDD patients
failed to meet the primary endpoint of improvement on HAMD-17 score in 2019.
We note that although shares of Sage fell on dampened investor sentiments, several analysts are of the view that the WATERFALL study data is fundamentally strong. Per these analysts, data from the study is likely to support an FDA approval for the candidate. They believe that if drugs like Prozac or Cymbalta can receive approval for treating MDD despite some failed studies, zuranolone holds potential to receive an approval on WATERFALL study data.
Moreover, the company is also evaluating zuranolone, co-initiated with a newly administered standard antidepressant therapy, as a potential acute rapid response treatment in patients with MDD in a phase III CORAL study. Top-line data from this study, anticipated later in 2021, is likely to be a key catalyst for the company going forward. Positive data from the study will likely strengthen a regulatory application for zuranolone along with WATERFALL study data.
Other companies developing a treatment for MDD include
VistaGen Therapeutics ( VTGN Quick Quote VTGN - Free Report) and Minerva Neurosciences ( NERV Quick Quote NERV - Free Report) . Zacks Rank
Sage Therapeutics currently has a Zacks Rank #3 (Hold). You can see
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