Reports Positive Phase 3 Emerge Study Data for Depression Treatment DT120 ODT

Definium Therapeutics announced positive topline results from its Phase 3 Emerge study for DT120 ODT (lysergide), a treatment for adults with major depressive disorder (MDD). The study successfully met its primary endpoint and all key secondary efficacy endpoints, demonstrating a statistically significant and clinically meaningful improvement in depression symptoms compared to placebo after a single dose.

Key Details

• Primary Endpoint Met: The study showed an 8.1 point placebo-adjusted reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (p<0.0001), the primary endpoint.
• Rapid & Durable Effect: The treatment demonstrated a rapid effect with a 14.2 point placebo-adjusted MADRS reduction at Week 1 and a durable effect with a 7.3 point reduction at Week 12.
• Safety Profile: DT120 ODT was reported to be generally well-tolerated, with no serious adverse events or suicidality signals identified during the trial.