Sage rebounds on Phase III PPD readout

Sage Therapeutics Inc. (NASDAQ:SAGE) jumped $33.99 (54%) to $96.65 Thursday after reporting that brexanolone (formerly SAGE-547) met the primary endpoint in a pair of Phase III trials to treat postpartum depression. Next year, the company plans to submit an NDA to FDA for the positive allosteric modulator (PAM) of GABA A receptor to treat PPD.

The 202B and 202C trials evaluated IV brexanolone in 122 patients with severe PPD and 104 patients with moderate PPD, respectively. In 202B, 60 and 90 µg/kg/hour doses of brexanolone both significantly reduced mean Hamilton Rating Scale for Depression (HAM-D) total score from baseline to 60 hours vs. placebo (19.9 and 17.7 points, respectively, vs. 14 points, p=0.0011 and p=0.0242; placebo-adjusted differences of 5.9 and 3.7 points). Study 202C tested only the higher dose of brexanolone and showed a mean reduction in HAM-D total score from baseline to 60 hours of 14.2 points vs. 12 points for placebo (p=0.016; placebo-adjusted difference of 2.2 points). Sage said the treatment effect was maintained to day 30 in both trials...