- One of Sage Therapeutics' pipeline assets scored an early victory in a late-stage study of postpartum depression patients, spurring a nearly 43% spike in the Cambridge, Massachusetts-based biotech's stock.
- The topline data, which came as the J.P. Morgan Healthcare Conference kicked off Monday, found patients taking SAGE-217 had a 17.8-point improvement on a rating scale for depression after two weeks of treatment. Those who were put on placebo also had an improvement, but it was significantly lower at 13.6 points.
- Investigators reported that 58% of the group treated with SAGE-217 experienced an adverse event versus 51% of the placebo group. There were two serious adverse events, one in each group.
Sage's pipeline of central nervous system drugs actually holds two postpartum depression candidates: brexanolone and SAGE-217, both of which work by regulating an inhibitory neurotransmitter known as GABA.
Brexanolone is further along in development, already under review at the Food and Drug Administration and outfitted with a potential brand name, Zulresso. Yet it has faced delays, and may be encumbered by a Risk Evaluation and Mitigation Strategy should it gain approval.
Still, brexanolone's approval looks likely. Analysts from Leerink noted the SAGE-217 postpartum data and previous clinical victories in major depressive disorder bode well not just for the drug itself, but also the similarly structured brexanolone.
"Bottom line, data look as positive as anticipated and provide further de-risking for the '217 efforts in major depressive disorder," Raymond James analyst Laura Chico wrote in a Jan. 7 note.
Another shot on goal with SAGE-217 appears to have reinforced investor optimism as well. Shares of Sage were trading at $139.13 apiece by market's close Monday — a price not reached since early October.
In addition to outperforming placebo, the topline data released Monday showed patients treated with SAGE-217 haven't experienced loss of consciousness, which has been a concern with brexanolone.
Those patients were also showing statistically significant differences in their improvement on the Hamilton Rating Scale for Depression by their third day of treatment compared to patients on placebo. The experiential group maintained that difference at each time point over two weeks.
After the two weeks, 45% of patients on SAGE-217 achieved remission on the rating scale versus 23% of patients on placebo.