Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder
Definium Therapeutics reported positive topline results from its Phase 3 Emerge study of DT120 ODT in Major Depressive Disorder, meeting the primary endpoint at Week 6 with a statistically significant 8.1-point placebo-adjusted improvement in MADRS scores. The single 100 µg dose demonstrated rapid efficacy with a 14.2-point reduction at Week 1 and durable effects of -7.3 points at Week 12, while being generally well tolerated with no serious adverse events or suicidality signals.
Key figures
- Drug Name
- DT120 (lysergide) ODT
- Phase Of Trial
- Phase 3
- Response rate drug
- 35%
- Remission rate drug
- 24%
- Primary endpoint diff
- -8.1
- Response rate placebo
- 7%
- Remission rate placebo
- 3%
- Primary endpoint p value
- <0.0001
- Secondary endpoint diff wk1
- -14.2
- Secondary endpoint diff wk12
- -7.3
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