SAGE Therapeutics Soars as Postpartum Depression Disappears in Four New Mothers
June 9, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass.-based SAGE Therapeutics announced today dramatic top-line data from a tiny clinical trial in women with postpartum depression (PPD) that showed its experimental drug SAGE-547 made a major impact when treating postpartum depression.
In the study, four women with PPD were given an intravenous injection of SAGE-547. Prior to the treatment, they were evaluated using the Hamilton Rating Scale for Depression (HAM-D). The patients’ baseline score was 26.5. A HAM-D rating of 24.0 or greater is considered severe depression. A score below 7.0 is called symptom-free. Within 60 hours, all four patients showed a HAM-D score of 1.8.
“These top-line results demonstrate an early but encouraging signal of activity in women with severe PPD and we believe further validate that the SAGE-547 mechanism of action has the potential to impact a broad range of disorders beyond epilepsy,” said Jeff Jonas, SAGE’s chief executive officer in a statement.
“Given the severity of this disorder and the strength of the initial signal, we plan to move from the initial open-label exploratory trial into a placebo-controlled trial to validate the activity signal as rapidly as possible," he said. "In parallel, we plan to advance several novel product candidates from our extensive compound library into development that we believe may be uniquely suited for the treatment of this devastating disorder.”
Postpartum Depression (PPD) affects up to 20 percent of women after childbirth. The drug, SAGE-547, modulates both synpatic and extra-synpatic GABAA receptors, which are drug targets for many disorders, including epilepsy, tremors and depression.
SAGE’s approach initially was focused on treatment for a severe form of epilepsy called refractory status epilepticus. In that disease, seizures are very severe and do not end, so patients are typically placed into a medically-induced coma.
One significant problem with this study is how small it was, evaluating only four patients. In a Forbes article by Matthew Herper, Nada Stotland, a professor at Rush Medical College in Chicago, said, “It’s as preliminary as preliminary can be with human subjects.”
In the same article, Adele Viguera, a psychiatrist at the Cleveland Clinic is quoted as saying, “It looks very exciting. It’s only four patients but what’s exciting is that you can treat someone relatively quickly for part-partum depression.”
The next step is a placebo-controlled trial. Oddly enough, Jonas himself is not convinced that SAGE-547 will be the company’s final depression drug, probably because it is an injectable, rather than an oral, medication. He stated in the Forbes article that he hopes to take the information from these trials about the drug’s blood levels that will allow the company to choose another, better suited molecule from the company’s chemical libraries, preferably one that is a pill with fewer side effects.
Sage stock welcomed the news, at least for a while. The stock has been on a fairly steady increase for the last year. On Aug. 18, 2014, shares sold for $27. On June 5, 2015, shares sold for $80.82. They are currently selling for $83.11.
The company did not respond to a request for an interview in time for deadline.
When Will Pfizer's Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016," said Chris Schott, an analyst at J.P. Morgan. "Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile."
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?