Sage Therapeutics, Biogen report positive zuranolone data in late-stage depression study

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• Sage Therapeutics (NASDAQ:SAGE) and Biogen (NASDAQ:BIIB) announce 12-month data for the cohort of patients (n=199), who received zuranolone 50 mg once nightly for 14-days as their initial dose in Phase 3 SHORELINE Study in major depressive disorder (MDD) followed up for up to one year.
• For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received.
• In the zuranolone 50 mg cohort, nearly 75% of patients responded to the initial 2-week treatment course. Of those who responded to the initial course and continued in the study, approx. 80% of those patients received at most one additional zuranolone treatment during their time in the study.
• 68.8% patients who initiated treatment with zuranolone 50 mg reported at least one adverse event, similar to the previously reported 30 mg cohort (68.0%).
• The majority of patients reported treatment emergent adverse events (TEAEs) with maximum severity of mild to moderate.
• Discontinuation and withdrawal from study due to TEAEs was 6.5% and 8.0%, respectively.
• Secondary endpoints included the percentage of patients who received repeat dosing with zuranolone as well as response and remission as evaluated by HAMD-17.
• SAGE shares rise 3.3% premarket at $40.20; BIIB up 1.06%.
• The companies plan to file marketing application for depression therapy in H2 2022.