Clinical TrialJun 22, 2026, 08:07 AM
Definium Therapeutics DT120 ODT Phase 3 Emerge Study Meets Endpoints
AI Summary
Definium Therapeutics announced positive topline results from its Phase 3 Emerge study of DT120 ODT for major depressive disorder (MDD). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in MADRS total score at Week 6, and all key secondary efficacy endpoints. DT120 ODT was generally well tolerated with no serious adverse events or suicidality signal, indicating a rapid, robust, and durable effect.
Key Highlights
- DT120 ODT Phase 3 Emerge study met primary endpoint with 8.1 point MADRS improvement over placebo at Week 6 (p<0.0001).
- Key secondary endpoint met with 7.3 point MADRS improvement over placebo at Week 12 (p<0.0001).
- Key secondary endpoint met with 0.9 point CGI-S improvement over placebo at Day 2 (p<0001).
- DT120 ODT was generally well tolerated; 99% of adverse events were mild-to-moderate.
- No serious adverse events or suicidality signal were identified in the study.
- 24% remission rate (MADRS <= 12) at Week 6 for DT120 ODT compared to 3% for placebo.
- 35% response rate (>=50% improvement) at Week 6 for DT120 ODT compared to 7% for placebo.
- Average time to clear End of Session Checklist (EoSC) was 5.8 hours, with 100% cleared by hour 8.
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