Neuroscience-focused, biopharmaceutical company Neurocrine Biosciences, Inc. (NASDAQ: NBIX) on Monday announced new Phase 2 results from the SAVITRI study showing statistically significant and clinically meaningful improvement in depression severity with once-daily oral administration of 1 mg osavampator (NBI-1065845).

The randomised, double-blind SAVITRI study enrolled 183 adults with major depressive disorder (MDD) who had an inadequate response to standard antidepressants. Patients received placebo, 1 mg, or 3 mg osavampator once daily for eight weeks. The trial met its primary endpoint, demonstrating a significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at Day 28 compared to placebo, with sustained benefit at Day 56.

Secondary endpoints showed statistically significant treatment response and remission rates at Day 56 with 1 mg dosing, while 3 mg showed favourable but not statistically significant effects. Exploratory analysis supported continued evaluation of 1 mg once-daily dosing in Phase 3 trials.

Osavampator was generally well tolerated, with no serious adverse events reported. The most common treatment-emergent adverse events, occurring in 5% or more of participants, were headache and nasopharyngitis, with similar rates to placebo.

Following the positive Phase 2 top-line findings, the company launched a Phase 3 registrational program in January 2025, which is now active and enrolling.