Benzinga | Dec 8, 2021 06:32AM EST

Sage Therapeutics and Biogen Announce New Analyses From LANDSCAPE Clinical Development Program Of Zuranolone In MDD Presented At The American College Of Neuropsychopharmacology Congress

Patients receiving zuranolone 50 mg in the WATERFALL Study demonstrated rapid improvements in depressive and anxiety symptoms, as early as the first measured timepoint (Day 3 for HAMD-17 and Day 8 for HAM-A), with average improvements maintained through the end of the study (Day 42)

Safety data from the WATERFALL Study was consistent with the zuranolone safety profile seen to date across the LANDSCAPE program

Zuranolone was generally well-tolerated in a subgroup of patients aged 65 years and older in the SHORELINE Study, showing similar efficacy and safety results in the datasets analyzed to that observed in the general study population

Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced new data from the LANDSCAPE clinical program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) presented at the American College of Neuropsychopharmacology (ACNP) Congress taking place December 5-8 in San Juan, Puerto Rico. Data from the SHORELINE and WATERFALL Studies in the LANDSCAPE clinical program further the understanding of the potential efficacy and safety profile of zuranolone for the treatment of MDD. Across the studies, zuranolone treatment led to improvements in depressive symptoms as well as in symptoms of elevated anxiety as assessed by multiple scales (HAMD-17, MADRS and HAM-A, respectively). In the WATERFALL Study, a rapid onset of effect in HAMD-17 was observed compared to placebo as early as Day 3, reaching statistical significance, followed by a stabilization of depressive symptoms through the follow-up period.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211208005327/en/

Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no increased incidence of adverse events (AEs) of weight gain, sexual dysfunction, or sleep disruption relative to placebo, symptoms that are often the cause of standard of care antidepressant discontinuation. In an analysis of a subgroup of patients (N=96) over the age of 65 in the SHORELINE Study, zuranolone efficacy and safety results for the initial 2-week dose treatment course were similar to that of the general study population. At the time of the analysis, retreatment data were only available for the zuranolone 30 mg cohort of the SHORELINE Study. In a subgroup of patients 65 years and older who responded to the initial 2-week treatment course of zuranolone 30 mg, and were followed for up to one year in the SHORELINE Study, more than half did not receive a second course of treatment during their time in the study.

"The data shared at ACNP continue to provide insight to help us better understand how zuranolone could impact the treatment of depression and potentially differentiate further from current antidepressants, if approved," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "The analysis conducted evaluating zuranolone's effects on measures of anxiety in patients with MDD is critical. Symptoms of anxiety are highly present in patients with depression, which can pose unique challenges to care. We are also pleased with the data for those 65 and older, who can struggle with current therapies to treat their depression. Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile in our clinical trials to date without the adverse events that are often associated with discontinuation of standard of care antidepressants."

ACNP presentations included data from the WATERFALL Study, a Phase 3 placebo-controlled trial that evaluated the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the ongoing open-label SHORELINE Study in MDD. In an oral session, an analysis from the WATERFALL Study assessing zuranolone (50 mg) on symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) showed improvements in symptoms of anxiety compared with placebo at Days 8 and 15. Additional data presented provided an efficacy analysis from the WATERFALL Study as measured by the Montgomery-?sberg Depression Rating Scale (MADRS) total score, which addresses core mood symptoms such as sadness, lack of energy, and suicidal thoughts. The group of patients receiving zuranolone (50 mg) showed rapid improvements in depressive symptoms and anxiety symptoms, as early as the first measured timepoint (Day 3 for HAMD-17 and Day 8 for HAM-A). Similar results have been observed across the LANDSCAPE program. Additionally, data from the SHORELINE Study support the potential of zuranolone as an oral, as-needed treatment for patients with MDD, including those age 65 and older

"The new data shared at ACNP further our confidence in the potential of zuranolone to help rapidly mitigate various symptoms associated with depression, including elevated anxiety," said Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences and Interim Head of Research and Development at Biogen. "As we continue to evaluate the totality of the data from the LANDSCAPE clinical develop program -- which includes the Phase 3 WATERFALL and SHORELINE Studies -- we aim to gain a more comprehensive understanding of how zuranolone may one day be a valuable option for people worldwide who seek a new way to treat depression."

Data presented at ACNP:

* Oral Presentation & Poster: Improvement in Symptoms of Depression and Anxiety With Zuranolone Treatment in Patients With Major Depressive Disorder: HAM-A Analysis From the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled WATERFALL Study

* Poster Presentation: Improvement in Severity and Symptoms of Major Depressive Disorder With Zuranolone Assessed by MADRS: Results From the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled WATERFALL Study

* Poster Presentation: Zuranolone in Major Depressive Disorder:Safety and Tolerability Results From the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled WATERFALL Study

* Poster Presentation: Zuranolone in Major Depressive Disorder: Results From the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, WATERFALL Study

* Poster Presentation: Zuranolone in the Treatment of Major Depressive Disorder in Patients ?65 Years of Age: Outcomes From the Phase 3, Naturalistic SHORELINE Study