Sage Therapeutics could soon win FDA approval for its postpartum depression (PPD) drug brexanalone, a 60-hour infusion supervised by a medical professional that could become the first drug to the market for the condition. But another experimental Sage drug that works in a similar way—but is a pill that patients could potentially take at home—called SAGE-217, could be a blockbuster depending on data from Phase 3 studies.
Sage now has those clinical results, saying that the drug met its primary and secondary goals in its Phase 3 ROBIN study that enrolled 151 women with severe PPD. Sage’s stock jumped more than 50 percent in trading this morning, up to nearly $150 apiece.
After two weeks of treatment with SAGE-217, treated patients in the trial showed an improvement of 17.8 points in a key depression rating scale, compared with 13.6 for patients on placebo, achieving the main goal of the study. That statistically significant difference remained after four weeks of follow-up. Sage also reported that 45 percent of patients went into remission after the two-week treatment course, while only 23 percent of placebo patients did.
Additionally, Sage said its drug showed statistically significant results in meeting its secondary goals of the study, which assessed anxiety and other measures of mental health.
Adverse effects were reported in 58 percent of treated patients and 51 percent of placebo, and the most common side effects were drowsiness, headache, dizziness, respiratory tract infection and others. There were no incidences of loss of consciousness, a worrisome side effect seen with brexanalone.
Stifel analyst Paul Matteis wrote in a research note that the results were an “outstanding outcome” and that the “safety and tolerability profile looks clean.” He added that the results bode well for the ongoing Phase 3 trial of SAGE-217 in major depressive disorder (MDD). The drug showed similarly positive results in a Phase 2 study in MDD.