SAGE Therapeutics (SAGE) Announces Positive Secondary Endpoint Data for SAGE-547 Phase 2

September 27, 2016 7:05 AM EDT
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Sage Therapeutics (Nasdaq: SAGE) announced positive results on secondary endpoints from its Phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression (PPD) at The Marcé Society for Perinatal Mental Health held September 26 – 28, 2016 in Melbourne, Australia. Secondary endpoints in the study, including the Edinburgh Perinatal Depression Scale (EPDS) and the Patient Health Questionnaire (PHQ-9) showed improvement through 30 days in the SAGE-547-treated group compared to the placebo group, demonstrating a strong durability of effect from SAGE-547 for over three weeks following the end of treatment. These data are consistent with previously reported top-line results showing SAGE-547 achieved the primary endpoint with a statistically significant reduction in the Hamilton Rating Scale for Depression (HAM-D) compared to placebo at 60 hours and maintained at similar magnitude through the 30-day follow-up. A similar statistically significant response was observed on other secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS) and Remission from depression, as determined by a HAM-D of less than 7. The company is pursuing publication of a comprehensive dataset from the Phase 2 trial in severe PPD in a peer-reviewed journal. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to SAGE-547 for the treatment of postpartum depression (PPD). There are no approved therapies specifically for PPD.

Data from the EPDS showed a mean change from baseline at 30 days in the EPDS total score for the SAGE-547 group of -13.5 compared with a mean change from baseline of -5.3 in the placebo group, which was a statistically significant difference (p=0.024). The EPDS is a patient-rated depressive symptom severity scale specific to the perinatal period. Data from PHQ-9 showed that at day 30, six patients (60%) in the SAGE-547 group compared to one patient in the placebo group had a score of 0 to 4 indicating minimal or no depression (p=0.024). The PHQ-9 is a self-administered rating scale which is used to measure severity of symptoms and response to treatment. Items cover the core major depression symptoms.

The secondary endpoints were measured as part of a Phase 2, multi-center, placebo-controlled, double-blind, 1:1 randomization trial that was designed to enroll up to 32 women. The population studied were 21 women with severe PPD (HAM-D ≥26) who developed severe depression either in the third trimester or within four weeks of childbirth. At baseline, the mean HAM-D scores for both the SAGE-547-treated group and the placebo group were greater than 28. The primary objective of the trial was to evaluate the effect of SAGE-547 on depression as measured by the HAM-D score, compared to placebo, at 60 hours. In addition, patients were monitored during a 30-day follow-up period to assess both safety and efficacy. Top-line results from the trial were announced in July 2016. SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and follow-up periods. A greater number of adverse events were reported in the placebo arm than in the treatment arm of the trial (4 of 10 on SAGE-547 and 8 of 11 on placebo). Similar number of patients reported Nervous System Disorder Adverse Events: 3 of 10 on SAGE-547 and 4 of 11 on placebo. Equal number of patients reported the cluster of dizziness, sedation or somnolence: 3 in each group. Fewer SAGE-547 patients reported Psychiatric Disorder Adverse Events: 0 of 10 on SAGE-547 and 5 of 11 on placebo.

Based on the positive results from the Phase 2 clinical trial in severe PPD, Sage has expanded its development program evaluating SAGE-547 for PPD with the initiation of two additional multi-center, placebo-controlled trials, one of which is a dose-ranging study of SAGE-547 in severe PPD patients and the other of which is studying the efficacy of SAGE-547 in moderate PPD patients. Top-line results from these two trials are expected in 2017.

“Postpartum depression represents a severely understudied and under-diagnosed class of patients. PPD is currently estimated to affect between 500,000 and 750,000 mothers in the U.S. each year. The unmet need for treatment in this vulnerable patient is significant. PPD carries an increased risk for suicide and it is one of the strongest predictors of suicidal ideation in new mothers,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. “The results of the secondary endpoints in this Phase 2 study of SAGE-547, including the Edinburgh Perinatal Depression Scale and PHQ-9, support the primary endpoints achieved in the trial. Data from this clinical program show improvement in the SAGE-547 group compared with placebo and the secondary endpoints are suggestive of improvement through 30 days in the SAGE-547 treatment group. These collective findings have the potential to create a paradigm shift in how PPD is thought about and – if our program is successful – how PPD might be treated in the future.”

The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy Designation to SAGE-547 for the treatment of PPD. Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. In the near term, Sage plans to meet with the FDA to discuss the development pathway for SAGE-547 in PPD.

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