Alto Neuroscience, Inc. (ANRO) announced disappointing results from its Phase 2b trial of ALTO-100 for major depressive disorder (MDD), leading to a significant drop in the company’s stock price. Despite the setback, Alto remains optimistic about its biomarker-driven approach and its other ongoing clinical trials.
Neurocrine Biosciences’ Phase 2 SAVITRI trial for depression therapy NBI-1065845 has reached its main goals in adults with major depressive disorder. The once-daily oral therapy indicated a statistically significant change from baseline in a clinical measure called the Montgomery-Åsberg Depression Rating Scale at Days 28 (primary) and 56 (secondary) compared to placebo. Neurocrine’s medical chief Eiry Roberts said, “The Phase 2 data are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies.”
Neurocrine Biosciences’ Phase 2 SAVITRI study has demonstrated the efficacy of NBI-1065845 in reducing depressive symptoms in adults with major depressive disorder. The study met its primary and key secondary endpoints, with NBI-1065845 showing statistically significant improvement in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 and Day 56 compared to placebo. NBI-1065845 was generally well-tolerated, with headache being the most common adverse event.
