Sage Therapeutics' shares jump on positive mid-stage data for depression drug

Shares in Sage Therapeutics jumped as much as 75 percent Thursday after the company announced that a mid-stage trial of SAGE-217 for the treatment of adults with moderate to severe major depressive disorder met its primary endpoint. CEO Jeff Jonas remarked "the positive activity and safety findings…support advancing the programme into later-stage clinical development."  

In the study, 89 adults with moderate to severe major depressive disorder were stratified according to antidepressant use and randomly assigned to treatment with SAGE-217 or placebo for 14 days, followed by a four-week follow-up period. The primary endpoint of the trial was a significant reduction versus baseline in the Hamilton Rating Scale for Depression (HAM-D) score.

Top-line results showed that treatment for 14 days with SAGE-217 was associated with a significant mean reduction in the HAM-D score of 17.6 points, compared to 10.7 for placebo. The data also indicated that 64 percent of patients in the SAGE-217 group achieved remission at day 15 as defined by a HAM-D score of 7 or less, versus 23 percent of placebo-treated patients.

Sage noted that reductions in the HAM-D score were observed after administration of the first dose of SAGE-217 and maintained for two weeks after the end of treatment, while rates of remission also remained significantly different at this time point. The drugmaker also recorded significant differences for all secondary endpoints of the study.

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Commenting on the news, Leerink analyst Paul Matteis described the study outcome as a "best-case scenario" for Sage, adding "it's hard to understate how meaningful these data are in the backdrop of the very significant unmet medical need in depression."

In May, SAGE-217, which Sage described as a "next-generation GABAA receptor positive allosteric modulator," was awarded fast track designation by the FDA for the treatment of major depressive disorder. "If we can substantiate these findings in Phase III, this could be an important first-line therapeutic option for everybody with depression," Jonas said. The executive also indicated that Sage would not seek a partner for SAGE-217. "What would be the goal of a big pharma partner besides cash, we can obtain that from the market," Jonas added.

Last month, Sage reported that two Phase III studies of its intravenous formulation of brexanolone in patients with moderate or severe postpartum depression met their main goals. Earlier this year, the company announced that the drug, formerly known as SAGE-547, missed the primary endpoint of a late-stage trial for the treatment super-refractory status epilepticus.

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