Phase III open-label SHORELINE Study of SAGE 217 shows no new findings in major depressive disorder.

The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with major depressive disorder (MDD) and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received.

Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile throughout the LANDSCAPE clinical program. Secondary endpoints included the percentage of patients who received repeat dosing with zuranolone as well as response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17). In the zuranolone 50 mg cohort, nearly 75% of patients responded to the initial 2-week treatment course. Of those who responded to the initial course and continued in the study, approximately 80% of those patients received at most one additional zuranolone treatment during their time in the study.

The SHORELINE Study, with nearly 1,000 patients enrolled to date, is comprised of multiple cohorts, including a completed cohort with zuranolone 30 mg as a starting dose (data previously reported in 2020 and earlier in 2021) and an ongoing cohort with zuranolone 50 mg as a starting dose; both cohorts are administered zuranolone once nightly for 14 days. Enrollment of an anticipated 300 additional patients in the 50 mg cohort is ongoing. The study provides real-world insight into the potential use of zuranolone, if approved, as an as-needed treatment for MDD and builds on the data assembled in the LANDSCAPE clinical program to date. Data from the LANDSCAPE clinical program has been presented at numerous medical and scientific conferences and the Companies plan to present additional data from the ongoing SHORELINE Study in future scientific forums.