The Sage Therapeutics Inc. announced positive results from the Phase 2 clinical trial assessing for SAGE-217, its experimental drug to treat people with moderate to severe major depressive disorder (MDD).
The trial conducted with 89 patients with MDD met its primary goal of a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) in 14 days of treatment.
At day 15, 64 percent of patients who received SAGE-217 achieved remission, defined as a score of seven or less on the HAM-D scale, compared with 23 percent of patients who received a placebo (p=0.0005).
Depression is a common mental illness characterized by persistent sadness, loss of interest and lack of ability to do everyday activities and work.
The clinical-stage biopharmaceutical company's shares soared 52 percent following the test results. The results pave the way for it to bring to market the first FDA-approved treatment for the disorder. The company plans to submit a marketing application for the drug, brexanolone, to the U.S. Food and Drug Administration in the first half of 2018.
Jeff Jonas M.D., chief executive officer of the company, said, "These very encouraging data suggest the potential of SAGE-217 in the treatment of MDD as well as other mood-related disorders that we may pursue."