Data from a clinical program evaluating the efficacy and safety of zuranolone was presented at the American College of Neuropsychopharmacology Congress. What new developments did they share?
Sage Therapeutics and Biogen presented new data from the LANDSCAPE clinical program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) at the American College of Neuropsychopharmacology (ACNP) Congress in San Juan, Puerto Rico.
Collected data from the SHORELINE and WATERFALL studies, both part of the LANDSCAPE clinical program, demonstrate the potential efficacy and safety profile of zuranolone for the treatment of MDD. Zuranolone treatment led to improvements in depressive symptoms and elevated anxiety symptoms, as assessed by multiple scales (HAMD-17, MADRS and HAM-A, respectively).
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 aged 18 to 64 years old with MDD as well as the ongoing open-label SHORELINE Study in MDD. In the WATERFALL Study, a rapid onset of effect as measured by HAMD-17 was observed compared to placebo by day 3, reaching statistical significance. A stabilization of depressive symptoms followed.
“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, MD, MPH, 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.”
In an oral session at ACNP, presenters shared an analysis from the WATERFALL Study assessing zuranolone (50 mg) on symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A). Participants treated with zuranolone showed improvements in symptoms of anxiety compared with placebo at days 8 and 15. Similar results have been observed across the LANDSCAPE program. Furthermore, data from the SHORELINE Study support the potential of zuranolone as an oral, as-needed treatment for patients with MDD, including those aged 65 and older.
“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.”
1. Sage Therapeutics. Sage Therapeutics and Biogen announce new analyses from the LANDSCAPE clinical development program of zuranolone in MDD presented at the American College of Neuropsychopharmacology (ACNP) Congress. News release. December 8, 2021. Accessed December 9, 2021. https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-new-analyses-landscape