Sage's drug for postpartum depression succeeds in mid-stage study
Sage Therapeutics Inc said its lead drug alleviated symptoms of severe postpartum depression, meeting the main goal of a small mid-stage study and sending the company's shares soaring in morning trading.
About one in seven women experience postpartum depression (PPD), a severe form of "baby blues" that eventually interferes with her ability to take care of the baby and handle daily tasks, according to the American Psychological Association.
There are no specific therapies for PPD. Existing options include standard antidepressants and psychotherapy.
A woman with PPD experiences a whirlwind of emotions, including severe anxiety, panic attacks, thoughts of harming herself or the baby, and feelings of worthlessness, shame, guilt or inadequacy.
Data on 21 patients showed that the drug, SAGE-547, achieved a statistically significant reduction in symptoms at 60 hours, compared to a placebo, on a standard depression scale used in clinical research, Sage said on Tuesday.
Typical antidepressants take about four-to-six weeks to take effect, trial investigator Samantha Meltzer-Brody told Reuters.
"So the rapid onset of response of this drug is unlike anything else available in the field," she added.
These findings represent a potentially new mechanism for the treatment of depression and other mood disorders, but need to be replicated in a larger late-stage trial, Chief Executive Jeff Jonas in an interview.
Cambridge, Massachusetts-based Sage has initiated an expansion of the mid-stage study to determine optimal dosing for the injectable drug.
Sage is also evaluating the drug for use in super refractory status epilepticus (SRSE), a life-threatening seizure disorder, as well as essential tremor.
Hedge fund Kerrisdale Capital said earlier this year that it had shorted the stock, expecting SAGE-547 to fail a key late-stage study involving patients with SRSE.
Data from this study is expected later this year.
"The consistency of the data demonstrated in the PPD trial boosts our confidence for a positive outcome for the Phase III SRSE study", SunTrust Robinson Humphrey analysts said in a note.
Overall, SAGE-547 is expected to generate peak sales of about $610 million by 2021, according to Thomson Reuters Cortellis.
However, Chardan Capital Markets analysts raised concerns about the drug's prospects, saying it had no robust patent protection.
Sage's follow-on program, SAGE-217, is an oral version of SAGE-547, and is expected to be ready for human testing by the end of 2016, CEO Jonas said.
The company's shares pared some gains and were up 34 percent at $45.13 in morning trading. They rose as much as 48 percent earlier.
(Reporting by Natalie Grover in Bengaluru; Editing by Savio D'Souza and Sriraj Kalluvila)