Sage Therapeutics Inc (NASDAQ:SAGE), looking to make a comeback, revealed data from another Phase 3 evaluating zuranolone in patients with Major Depressive Disorder (MDD).
Though the trial achieved the primary endpoint of statistically significant improvements in depressive symptoms compared with placebo at Day 15, some results have made investors react, thus sending SAGE shares down early Tuesday.
Zuranolone whiffed on a key secondary endpoint, the CGI-Severity scale (measures illness severity), only achieving a -0.2 difference compared to placebo.
And though patients who responded positively to the HAMD-17 (Depression score) scale at day 15 maintained 86.1% of their improvement four weeks after stopping treatment, that figure did not come in as statistically significant.
Another measurement using the MADRS scale (Depression Rating score) also showed how responders retained 87.6% of their improvement, failing to hit statistical significance as well.
Regarding safety, patients in the treatment arm reported higher rates of treatment-related side effects vs. placebo including drowsiness (15.3% vs 3.0%), dizziness (13.8% vs 2.2%), headache (10.8% vs 7.8%) and sedation (7.5% vs 0.4%).
CEO Barry Greene said “Sage’s expertise in the modulation of the GABA receptor pathway in the brain, coupled with insights on the treatment wants and needs of clinicians and patients, has resulted in our targeting a unique benefit/risk profile with the development of zuranolone supported to date by the data generated in the WATERFALL Study and the broader Landscape and NEST programs.”
SAGE shares shriveled $7.56, or 10.4%, to $65.30