Talk Bio

Definium Therapeutics announced positive topline results from its Phase 3 Emerge study of DT120 ODT, a lysergide formulation, for major depressive disorder (MDD). The trial met its primary endpoint with an 8.1 point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6, with a p value < 0.0001. DT120 ODT also met all key secondary endpoints, including a 7.3 point placebo-adjusted improvement at week 12 (p < 0.0001) and a 14.2 point improvement at week 1 (p < 0.0001). The response rate (at least 50% improvement on MADRS) was 35% for DT120 ODT versus 7% for placebo at week 6, with remission rates of 24% versus 3% respectively. The treatment was generally well tolerated, with 99% of treatment-emergent adverse events being mild to moderate severity, and no serious adverse events or increases in suicidal ideation were observed. Discontinuation rates were comparable between groups, and all participants met end-of-session criteria within eigh...