Sage Therapeutics, Biogen highlight data showing zuranolone well-tolerated in MDD

Sage Therapeutics Inc. and Biogen Inc. released 12-month data showing zuranolone was generally well-tolerated among adults with major depressive disorder.

A total of 199 patients received zuranolone 50 mg once per night for 2 weeks as their initial dose in the ongoing phase 3 open-label SHORELINE Study, with potential for 12 months of follow-up. The study is part of the LANDSCAPE clinical program and was designed to naturalistically follow adults with MDD and examine zuranolone’s safety and tolerability in addition to the need for repeat dosing for up to 1 year.

“We believe zuranolone has the potential to offer an innovative treatment approach that may enable patients with MDD to experience reductions in depressive symptoms quickly, achieve related improvements in functioning and well-being, and maintain long treatment free intervals without the types of burdensome side effects that are often associated with discontinuation of standard of care antidepressants,” Barry Greene, CEO of Sage Therapeutics, said in a press release.

“The SHORELINE Study helps provide important information on how zuranolone, if approved, could be used to treat people with MDD,” Greene continued. “We are pleased by the progress made with zuranolone throughout 2021, and the data we have generated in clinical development to date supports our belief in the overall profile of zuranolone and its potential to make a profound difference in the lives of many patients living with MDD.”

Data analyzed thus far related to the primary endpoint of safety and tolerability showed zuranolone was generally well-tolerated, and researchers reported no new safety findings or trends in the long-term safety data regardless of how many zuranolone courses a patient received. Zuranolone showed fast and continued improvements in depressive symptoms, as well as a well-tolerated safety profile for the duration of the LANDSCAPE clinical program.

Percentage of patients who received repeat zuranolone dosing, as well as response and remission according to the 17-item Hamilton Rating Scale for Depression, served as the secondary endpoints. Approximately 75% of patients in the zuranolone 50 mg cohort responded to the initial 2-week treatment course. Approximately 80% of responders to the initial course who continued in the study received at most one additional zuranolone treatment while in the study.

“These new data further reinforce positive findings from multiple late-stage studies of zuranolone and underscore the potential of zuranolone as a well-tolerated, rapid-acting and durable treatment option for depression,” Priya Singhal, MD, MPH, head of Global Safety and Regulatory Sciences and interim head of R&D at Biogen, said in the release.