Sage Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Highlights Pipeline and Business Progress
February 24, 2021 at 06:30 AM EST
Today, Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2020.
“Although 2020 was a challenging year, Sage’s commitment to rigorous science, innovation and disciplined execution resulted in significant progress across all of our brain health franchises, strongly positioning us in our efforts to deliver revolutionary medicines to millions of patients,” said Barry Greene, chief executive officer at Sage Therapeutics. “Our collaboration with Biogen enhances our strategic, financial, and operational flexibility, enabling our plans to expand and accelerate our pipeline and extending the potential impact of our product candidates, if we’re successful, to more than 450 million patients worldwide. In the first months of 2021, we’ve already begun to realize this expansion and acceleration with the progression of multiple early-stage programs. I believe 2021, with 10 expected data readouts, will be a transformational year for Sage in our mission to become the leading brain health company in the next five years.”
KEY 2020 UPDATES
Zuranolone SHORELINE Study data: In October 2020, Sage reported positive, interim topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study of zuranolone in MDD. The SHORELINE Study is designed to evaluate the safety and tolerability of zuranolone in adults for up to one year.
Interim topline data from the SHORELINE Study showed:
Corporate restructuring: In April 2020, Sage completed a restructuring intended to enable the Company to advance its corporate strategy and pipeline throughout the COVID-19 pandemic and beyond.
Zuranolone is being evaluating as a potential rapid-acting, short-course treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. Sage initiated three Phase 3 clinical studies in 2020. If successful, these studies, along with the rest of the program, may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.
The Company expects the following zuranolone data readouts in 2021:
Sage is also evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to align with FDA on data to support a potential future new drug application (NDA) with the FDA. Additional development plans for zuranolone will be confirmed and announced as part of the Company’s strategic collaboration with Biogen.
Additionally, Sage’s collaboration with Shionogi & Co., Ltd. is progressing. In 2020, Shionogi initiated a Phase 2 trial with zuranolone in Japan for the treatment of MDD. Shionogi anticipates that this Phase 2 study will finish in the third quarter of 2021. Under the terms of the collaboration, Shionogi is responsible for all clinical development, regulatory filings and commercialization of zuranolone for MDD, and potentially other indications, in Japan, Taiwan and South Korea.
The following milestones are expected for the neurology franchise in 2021:
Additional development plans for SAGE-324 will be confirmed and announced as part of the Company’s strategic collaboration with Biogen.
Positive data with SAGE-718 to date include results from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-718 in a cohort of patients with early HD. In that study, SAGE-718 was well tolerated with no serious adverse events or adverse events leading to treatment discontinuation and patients demonstrated improved performance, compared to baseline, on assessments of executive functioning, a core feature of early HD.
Ongoing trials with SAGE-718:
The following milestones are expected for the neuropsychiatry franchise in 2021:
Additionally, the Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in late 2021. Details of this trial will be informed by results from the Phase 2a studies and earlier work.
Results from the Phase 1 studies will inform further development of these programs.
Additionally, the Company recently announced plans to advance SAGE-319 and SAGE-421 to preclinical studies.
Other Development Opportunities
ANTICIPATED 2021 MILESTONES
FINANCIAL RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2020
Conference Call Information
About Sage Therapeutics
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