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Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder

DFTX
  • Definium Therapeutics announced positive topline results from the Phase 3 Voyage study evaluating DT120 ODT 100 µg for generalized anxiety disorder (GAD).
  • The study met its primary endpoint & all key secondary efficacy endpoints, showing a statistically significant placebo-adjusted reduction in Hamilton Anxiety Rating Scale (HAM-A) scores of 5.4 points at Week 12 (p<0.0001).
  • Participants receiving DT120 ODT achieved a least squares mean change of -11.6 in HAM-A scores compared to -6.2 for the placebo group, resulting in a standardized effect size of 0.81.
  • Efficacy was rapid, with significant improvements observed as early as Day 2 & sustained through all post-baseline timepoints in Part A.
  • DT120 ODT demonstrated a 43% response rate (≥50% reduction in HAM-A) at Week 12 versus 16% for placebo, & a 14% remission rate versus 4% for placebo.
  • The treatment was generally well tolerated, with adverse events being mild to moderate, transient, & predominantly occurring on the day of dosing.
  • No new safety signals were identified, including no reports of suicidality or suicidal behavior.
  • On the day of dosing, the average time to meeting structured end-of-session checklist criteria was 6.4 hours, with 92% of participants meeting criteria by hour 8.
  • This marks the second positive Phase 3 readout for DT120 ODT, following the successful Emerge study in major depressive disorder announced in June.
  • A second Phase 3 GAD study named Panorama is expected to report topline results in September.
  • Definium Therapeutics will host a webcast at 8:00 am EDT to review these Phase 3 voyage study results.
  • DT120 ODT is a proprietary formulation of lysergide designed as a single-dose treatment option with a potential duration of effect lasting 12 weeks.
  • The study enrolled 214 adults with DSM-5-confirmed GAD across approximately 35 sites in the United States.
  • DT120 ODT has received Breakthrough Therapy designation from the FDA for the treatment of GAD.