Sage Therapeutics’ depression drug falls short at Phase 3
pharmafile | December 6, 2019 | News story | Medical Communications, Research and Development | Sage Therapeutics, major depressive disorder, pharma, trial failure
Sage Therapeutics has announced that its candidate SAGE-217 flopped in Phase 3 trials investigating its efficacy in symptom reduction for major depressive disorder (MDD) in adult patients.
The drug failed to meet its primary endpoint of significant reduction from baseline in MDD symptoms, as measured on the 17-item Hamilton Rating Scale for Depression (HAM-D) after 15 days of treatment.
A 30mg dose of the drug demonstrated a mean reduction of 12.6 on the HAM-D compared to 11.2 with placebo. Despite this, after three, eight and 12 days of treatment, this therapy dosage recorded a “statically significant” reductions in patients.
Sage did note some successes of the study: if the 9% of participants with no measureable drug concentration were omitted from the results, the study reached statistical significance at all time points through to Day 15. Additionally, when only patients with a HAM-D score of 24 or higher were included, the study also showed statistical significance at all time points through to Day 15.
“This study did not meet the primary endpoint. With that, the data are supportive of the activity of SAGE-217 in MDD given the statistical significance at the majority of time points, and in relevant populations,” explained Dr Jeff Jonas, Chief Executive Officer at Sage. “Notwithstanding the finding on the primary endpoint, the drug displays good activity on most measures. We understand that drug development is an iterative process. In this study, we’ve gathered new data on SAGE-217, data we believe support our hypothesis that SAGE-217 has a unique profile with the potential for rapid and robust onset with durable effect.”
Dr Steve Kanes, Chief Medical Officer at Sage, added: “These study results reinforce that we have an active drug with safety data that are consistent with the two earlier pivotal trials in MDD and PPD. As a designated breakthrough therapy, we are evaluating the path forward to more fully inform a potentially expedited pathway to approval, and any amendments we might consider to the ongoing SAGE-217 pivotal programme.”
Sage is currently testing the drug in a range of other trials, including one in MDD and on in postpartum depression which have already shown positive data, as well as three others which are ongoing.
Matt Fellows
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