On Monday, Sage Therapeutics announced new data from a clinical Phase 3 study with women suffering from postpartum depression. During early trading the Sage stock was trading more than 40% up on the news.
On Monday, Sage Therapeutics announced new data from a clinical Phase 3 study with women suffering from postpartum depression (PPD) featuring the company’s novel oral drug candidate SAGE-217. During early trading the Sage stock was trading more than 40% up on the news. It was a little more than a year ago that Sage in a Phase 2 study showed significant effect with SAGE-217 in major depressive disorder, but to understand today’s big reaction one have to look at Sage’s initial product candidate Zulresso, currently under FDA review to be approved in PPD.
When under public scrutiny with a FDA-assigned advisory committee ahead of the agency’s final approval decision, it emerged that Zulresso caused uncontrolled fainting and sudden sleepiness in women with PPD under treatment. Zulresso is not an oral pill like SAGE-217, but is administered through intravenous infusion in clinics, which somewhat mitigates the adverse event circumstances with that drug. The point of the oral drug however is to enable patients to self-administer, but if the adverse event profile would turn out to be similar to Zulresso then much of the benefits with an oral drug would be void as patients would have to remain under strict supervision of healthcare professionals. Plus off course the fact that showing efficacy in cognitive conditions is a notoriously difficult task to achieve.
The data released from the Phase 3 trial turned out to be a major relief. First of all efficacy versus placebo was clearly better for those receiving SAGE-217, the drug was statistically significantly superior both on standard depression scales but also with regard to the number of patients that achieved remission within the study’s four week readout time. And just as importantly, the safety profile for SAGE-217 looked very good, with no signs of loss of consciousness as seen with Zulresso. The path now appears open for yet another Sage treatment in PPD and by the end of this year we will also learn if SAGE-217 also works in a larger Phase 3 general depression study.
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