OCTOBER 4, 2021 • INVESTOR RELATIONS
Improvement achieved in measurements of overall quality of life, functioning and general well-being achieved at Day 15 and sustained at Day 42
Consistent and differentiated safety and tolerability profile seen across clinical program
Sage to host conference call on October 4, 2021 at 8:00am ET
CAMBRIDGE, Mass. – October 4, 2021 – Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced new data from the LANDSCAPE and NEST clinical development program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD) presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 2-5, 2021. Presentations include data from the WATERFALL Study, a Phase 3 placebo-controlled trial evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the open-label SHORELINE Study in MDD and cross-study analyses from across the LANDSCAPE and NEST programs. Collectively, the studies show reductions in depressive symptoms with zuranolone-treated patients such as consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3. Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no evidence of withdrawal, weight gain, sexual dysfunction, euphoria, or sleep disruption; symptoms that are typically the cause of treatment discontinuation with current standard of care antidepressants. In pooled analyses from the LANDSCAPE and NEST programs of SF-36v2, a patient self-reported measure of general health, zuranolone treatment led to rapid improvement in quality of life and overall health across all functioning and well-being domains at Day 15 and across all domains at Day 42 (Day 45 in ROBIN Study).
Additional data presented summarized clinical data from the literature on onset of effect of current treatment options in MDD demonstrating there is a need for new treatment options with the potential for rapid response.
“The collection of data presented at ECNP showcases the LANDSCAPE and NEST programs, in totality, where we have seen a very consistent and differentiated profile for zuranolone. The efficacy data across the clinical development program have demonstrated a rapid onset of activity, consistent reductions in depressive symptoms and a two-week treatment regimen that may offer the potential to treat-as-needed. The data also include a robust safety database with more than 3,500 patients treated, showing that zuranolone has been well tolerated to date,” said Steve Kanes, M.D., PhD., chief medical officer at Sage Therapeutics. “We believe these data represent the potential for a benefit-risk profile for zuranolone that may be differentiated from the most prescribed depression drugs on the market, and may be welcomed by patients, if approved.”
“The data presented at ECNP further emphasize that zuranolone dosed once daily for two weeks has the potential to produce a rapid reduction of depressive symptoms within days for both major depressive disorder and postpartum depression and a differentiated, well-characterized safety profile,” said Katherine Dawson, M.D., head of the Therapeutics Development Unit at Biogen. “Collectively these data represent positive steps in Biogen’s journey to expand our footprint in neuropsychiatry and innovate for the millions of people who need new options to address mental health conditions.”
“The efficacy and safety data observed with zuranolone across the LANDSCAPE and NEST clinical program indicate that, if approved, it may offer the potential for people with MDD and PPD to experience a rapid reduction in their depressive symptoms without side effects such as weight gain, sexual dysfunction and sleep disruption that are often associated with treatments currently on the market,” said Anita H. Clayton, M.D., Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine. “Patients in the trials are also indicating through the patient outcome measures that zuranolone helped with their overall well-being.”
Data presented at ECNP:
- Oral Presentation: Zuranolone in major depressive disorder: topline results from the Phase 3, multicenter, randomized, double-blind, placebo-controlled WATERFALL Study
- Poster Presentation Title: Zuranolone 30 mg in major depressive disorder: results through 1-year follow-up from the Phase 3, open-label, SHORELINE Study
- Poster Presentation: Exploring the rapidity of treatment effect for current treatment options for major depressive disorder