For SAGE Therapeutics Inc. (SAGE), next quarter is going to be a make-or-break period as an important catalyst is coming its way.
SAGE is a clinical-stage biopharmaceutical company focused on developing novel medicines to treat life-altering central nervous system, or CNS, disorders.
The Company’s lead product candidate is SAGE-547, which is under phase III trials for super-refractory status epilepticus, or SRSE, and post-partum depression, or PPD.
An epileptic seizure that lasts more than 5 minutes is known as status epilepticus, and it affects about 150,000 people each year in the U.S. Postpartum depression, or PPD, is a mood disorder impacting women after childbirth.
The phase III trial of is SAGE-547 for super-refractory status epilepticus, dubbed STATUS, is nearing completion of enrollment.
The STATUS study is designed to enroll 126 patients and its primary endpoint is continued resolution of status epilepticus for 24 hours. The Company expects to report top-line results from the STATUS trial in the third quarter of 2017.
The phase III clinical program evaluating SAGE-547 as a potential treatment for PPD, consisting of separate placebo-controlled trials in severe PPD patients (202B) and in moderate PPD patients (202C), is collectively known as the Hummingbird Study.
Sage expects to report top-line results from the Hummingbird Study in the second half of 2017.
Two other clinical drug candidates in the Company’s pipeline are SAGE-217 and SAGE-718.
— SAGE-217 is under phase II development for postpartum depression, major depressive disorder, essential tremor and Parkinson’s disease.
The top-line data from the phase II studies of SAGE-217 in postpartum depression and essential tremor are anticipated in the second half of 2017.
— SAGE-718, which has a potential in the treatment of a range of neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms, recently entered phase I testing.
A phase I single ascending dose (SAD) trial…