Neurocrine Biosciences (NASDAQ: NBIX) announced encouraging results from its Phase 2 SAVITRI trial for depression therapy NBI-1065845, developed in partnership with Takeda Pharmaceutical (NYSE: TAK). The trial, designed to test two dose levels of NBI-1065845 (TAK-653) as a late-line option in adults with major depressive disorder (MDD), met its primary and key secondary endpoints. Topline data revealed that the once-daily oral therapy showed a statistically significant change from baseline in the Montgomery-Åsberg Depression Rating Scale at Days 28 (primary) and 56 (secondary) compared to placebo. One dose demonstrated an improvement over the placebo, while the other dose indicated a trend toward improvement on days 28 and 26. The study drug was well tolerated, with the most common adverse event being headaches. There were no deaths or serious adverse events, and discontinuation rates were low during the trial. Dr. Eiry Roberts, Neurocrine’s medical chief, expressed optimism about the findings and the potential for further research. “The Phase 2 data from the SAVITRI study are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies,” said Roberts.
Neurocrine’s Phase 2 Depression Therapy Trial Meets Primary Goals
