Sage Therapeutics ($SAGE) was up 35% in early trading on positive top-line Phase II data to treat severe postpartum depression (PPD). Women with this specific condition have no other FDA-approved treatment options.
Wall Street embraced the results, sending the company’s market cap north of $1.5 billion. That’s despite a very small sample size for the trial: 21 patients in total with only 10 patients in the treatment arm.
The candidate in the PPD study, SAGE-547, is Sage’s lead. It’s also in a Phase III trial to treat super-refractory status epilepticus (SRSE). Top-line data for this up to 140 patient trial are expected before year end. SAGE-547 has Orphan Drug Designation from the FDA for the SRSE indication and is being developed under a Fast Track designation. In April, Sage also had positive Phase II data for it to treat patients with essential tremor.
The PPD data, despite the very small sample size, were striking. Of the 10 treated patients, 7 achieved remission within 60 hours of treatment—with that same number in remission after 30 days of follow-up. In the 11-patient placebo group, only one patient had remission at 60 hours while two did so at 30 days.
“This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date,” said the study’s primary investigator, Dr. Samantha Meltzer-Brody, an associate professor and director of the UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders, in a statement.
She added, “The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data show the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”
Next, Sage plans to expand this Phase II study to determine the best dosage. It will also move into a moderate population with the expanded trial. It expects to start enrollment before year end. SAGE-547 is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. It is given as an intravenous injection.
The Phase II trial specifically evaluated women who were no longer breastfeeding with a major depressive episode that started no earlier than the third trimester of pregnancy and no later than four weeks after delivery. They had all had PPD for less than 6 months.
The study achieved its primary endpoint of a significant reduction in the Hamilton Rating Scale for Depression (HAM-D) score compared to placebo at 60 hours with a 20-point mean reduction, as compared to a baseline score of more than 28 for both treatment and placebo groups. That was more than 12 points better than placebo.
“We believe these data represent an unprecedented opportunity for developing treatments for PPD, and believe that our findings will serve as a paradigm shift in how the disease is thought about and, if our development program is successful, how PPD might be treated in the future,” said Sage CMO Dr. Steve Kanes in the statement.
- here is the announcement
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