CAMBRIDGE -
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.
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.
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-Asberg 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
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
About Major Depressive Disorder (MDD)
Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 19 million people in the
About Zuranolone
Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the
Zuranolone is being evaluated in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes two placebo-controlled studies of zuranolone in patients with PPD (ROBIN and SKYLARK Studies). Additionally,
About
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by
In 2020, Biogen launched a bold 20-year,
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential, benefits, safety and efficacy of zuranolone; the potential clinical effects of zuranolone; the clinical development program for zuranolone; clinical development programs, clinical trials and data readouts and presentations for zuranolone; the potential treatment of MDD; the potential of Biogen's commercial business and pipeline programs, including zuranolone; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'potential,' 'possible,' 'will,' 'would' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of zuranolone; unexpected concerns may arise from additional data, analysis or results of clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including zuranolone; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
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