The company’s shares were up 43 percent at US$48.15 in premarket trading.
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Postpartum depression is an affective disorder that impacts women after childbirth, and may include significant functional impairment, depressed mood or loss of interest in the newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem.
“The unmet need in the PPD patient population can not be overstated”. Currently, there are no approved therapies that specifically treat PPD, and therapeutic options in severe PPD are limited as well.
Sage Therapeutics, which was founded in Cambridge, Massachusetts in 2010, has been working on new treatments to help people suffering from life-altering central nervous system (CNS) disorders.
“In the context of treatment-resistant depression where (Otsuka’s) Abilify and (AstraZeneca’s (AZN)) Seroquel show 2-4 point differences, we believed a 5-point drug/placebo HAM-D17 delta for SAGE-547 would warrant further clinical development”, Leerink analyst Paul Matteis wrote in a research note.
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. The 21 participants involved in the study were adult females who required inpatient treatment as a result of their condition.
Sage, which develops drugs for central nervous system disorders, said the drug met its primary endpoint, demonstrating a more than 20-point improvement in depression scores 60 hours after treatment. The results showed that seven out of the 10 SAGE group members achieved the targeted results, compared to one out of 11 in the placebo group.
Sage-547 was generally well-tolerated, with no serious adverse events reported during the treatment and follow-up periods, the biotech company said.
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“The big problem (as many are pointing out this morning) is that the placebo group response is typically rather high in antidepressant trials, and with this small a number of patients, these statistics could still be just an artifact”, Lowe wrote.
