Policy & Regulation
Sage Therapeutics Touts Positive Interim, Topline Zuranolone Safety and Tolerability Data from Open-Label SHORELINE Study in Patients with MDD
16 October 2020 - - US-based biopharmaceutical company Sage Therapeutics, Inc. (NASDAQ: SAGE) has reported interim, topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study, the company said.

This clinical study was designed to naturalistically follow patients with major depressive disorder and evaluate the safety and tolerability of zuranolone 30 mg in adults for up to one year.

In May 2020, the protocol was amended to include a 50 mg dose of zuranolone. For the primary endpoint of safety and tolerability, the data analyzed to date show that zuranolone was generally well-tolerated in the 30 mg dose and among the initial patients treated with the 50 mg dose.

Adverse events reported in the trial during the period analyzed were generally consistent with results seen in previous clinical trials.

Secondary endpoints included response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17) and the number of times a patient received retreatment.

At the time of this analysis, patients with a clinical response (decrease in HAMD-17 baseline score of ≥50%) to the initial 14-day course of zuranolone 30 mg used a mean number of 1.9 treatments per year.

As the first naturalistic, longitudinal, clinical development trial conducted in MDD, the SHORELINE Study provides real world insight into the potential use of zuranolone, if successfully developed and approved as an as-needed treatment for MDD, and builds on the data assembled in the LANDSCAPE clinical program.

The company plans to report comprehensive data from the 30 mg dose in the first half of 2021 and will include additional subsets of data within the primary and secondary endpoints.

Select data will be reserved for presentation at medical and scientific conferences and in peer-reviewed journal articles.

Sage's Phase 3 SHORELINE Study is evaluating the safety and tolerability of zuranolone 30 mg and 50 mg in adults 18-75 who have MDD as defined by a baseline HAMD-17 total score ≥20. The original study design included a zuranolone 30 mg dose administered once nightly for 14 days.

725 people with MDD (HAM-D ≥ 20) were treated with a first dose of zuranolone 30 mg once daily for 14 days.

The mean baseline HAM-D score at entry into the study was 25.3 ± 4.1 (n=725).

Of the 725 patients treated, 143 (19.7%) did not achieve response to the first course and exited the study. Subjects were required by protocol to achieve response to continue into the naturalistic follow-up period.

At Day 15 of the initial course of patients who only received 30 mg in the study, the mean change from baseline was -14.9 ± 7.1 (n=640); 458 (71.6%) patients achieved response and 255 (39.8%) achieved remission (HAM-D ≤ 7).

304 patients were on pre-existing antidepressant therapy which was continued, while 421 were on no ADT; there were no meaningful differences in efficacy outcomes between the two groups.
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