Definium’s LSD formula produces ‘best data ever seen’ in a pivotal depression trial, CEO says

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1. 1h ago

   Definium Reports Positive Phase 3 Results for LSD-Based Depression Drug DT120

   Definium Therapeutics announced that its DT120 orally disintegrating tablet met all primary and key secondary endpoints in the Phase 3 Emerge study for major depressive disorder. CEO Daniel Hang F. Barrow described the results as the "best data ever seen" in a pivotal depression trial. The company is currently awaiting data from a second pivotal trial.

   What's confirmed:

   • The Phase 3 Emerge study of DT120 ODT met its primary endpoint with an 8.1 point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale at week 6.
   • DT120 ODT met all key secondary endpoints, including a 14.2 point improvement at week 1 and a 7.3 point improvement at week 12.
   • The response rate at week 6 was 35% for DT120 ODT compared to 7% for the placebo group.
   • Remission rates at week 6 were 24% for DT120 ODT and 3% for the placebo group.
   • The trial included 149 patients.
   • Ninety-nine percent of treatment-emergent adverse events were mild to moderate, with no serious adverse events or increases in suicidal ideation observed.
   • Definium shares rose following the announcement.
   • CEO Daniel Hang F. Barrow stated the data represents the best ever seen in a pivotal depression trial for an LSD-based therapy.

   Still unconfirmed:

   • Definium Therapeutics stock 12-month price target was raised to $49.4.
   • Jefferies described the efficacy data as profound.
   • Stifel stated the results exceeded expectations.
   confidence 100%