New York — Definium Therapeutics announced positive topline results from a Phase 3 study evaluating a single dose of DT120 orally disintegrating tablets in adults with major depressive disorder.
The randomized, double-blind, placebo-controlled Emerge study met its primary endpoint and all key secondary efficacy endpoints. DT120 is a 100-microgram orally disintegrating formulation of lysergide.
At week six, patients receiving DT120 showed a 13.3-point average reduction from baseline on the Montgomery-Åsberg Depression Rating Scale, compared with a 5.2-point reduction for patients receiving placebo. The placebo-adjusted difference was 8.1 points and was statistically significant.
The treatment effect was observed as early as week one, when the placebo-adjusted improvement was 14.2 points. At week 12, the placebo-adjusted improvement remained 7.3 points.
“The Emerge topline results represent unprecedented and highly differentiated efficacy, demonstrating that a single dose of DT120 ODT can deliver rapid, robust, and durable relief in MDD,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “As the first of our Phase 3 studies to report results, Emerge marks a major milestone in our development program and strengthens our confidence in DT120 as a potential best-in-class treatment for mental health disorders. These findings could support a fundamentally new approach to treating MDD for patients and providers who continue to face the limitations of existing treatment options. We are deeply grateful to the patients and investigators who participated in this trial. Grounded in decades of scientific research, these results bring us one step closer to potentially delivering a transformative new treatment option as we advance toward FDA submission.”
The study enrolled 149 participants, including 75 who received DT120 and 74 who received placebo. The average baseline depression score was 35 in the DT120 group and 34 in the placebo group.
At week six, 35% of patients receiving DT120 achieved a reduction of at least 50% in their depression scores, compared with 7% of those receiving placebo. Remission rates were 24% for DT120 and 3% for placebo.
DT120 also produced statistically significant improvements on the Clinical Global Impressions-Severity Scale at day two and weeks six and 12.
The treatment was generally well tolerated, with 99% of treatment-emergent adverse events classified as mild or moderate. Most were temporary and occurred on the day of dosing. Definium reported no serious adverse events, new safety signals or increase in suicidal thoughts or behavior.
Participants receiving DT120 met the study’s end-of-session discharge criteria after an average of 5.8 hours and a median of 5.1 hours. All participants met the criteria by eight hours after dosing.
“Many patients with MDD aren’t helped by existing treatments, often experiencing partial responses, frequent medication changes, and long-term side effects,” said John Sonnenberg, Ph.D., Emerge principal investigator, clinical psychologist, founder of Uptown Research Institute, and faculty member at Northwestern University Feinberg School of Medicine. “The Emerge topline results demonstrate that a single dose of DT120 ODT can produce a meaningful and durable benefit for people with depression. Importantly, these results stand apart from existing treatments, representing a potentially new paradigm for the management of major depression.”
