Definium Therapeutics (NASDAQ:DFTX) shares climbed about 53% on Monday after the biopharmaceutical company reported positive topline results from its Phase 3 Emerge study evaluating DT120, an orally disintegrating formulation of lysergide (LSD), in adults with major depressive disorder (MDD).
The randomized, double-blind, placebo-controlled trial met its primary endpoint and all key secondary efficacy endpoints.
Patients receiving a single 100-microgram dose of DT120 showed an 8.1-point placebo-adjusted improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at Week 6, the study's primary endpoint, with statistical significance of p<0.0001.
Definium also reported a 7.3-point placebo-adjusted improvement in MADRS scores at Week 12, a secondary endpoint, and said the treatment demonstrated rapid effects, including a 14.2-point placebo-adjusted reduction at Week 1.
The company said DT120 was generally well tolerated, with 99% of treatment-emergent adverse events classified as mild to moderate. No serious adverse events, suicidality signal, or new safety concerns were identified, and discontinuation rates were low and comparable with placebo.
“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,” Definium Therapeutics CEO Rob Barrow said in a statement.
“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.”
Dr John Sonnenberg, founder of Uptown Research Institute and principal investigator for the Emerge study, highlighted that many patients with MDD are not helped by existing treatments, pointing to partial responses, frequent medication changes, and long-term side effects.
"The Emerge topline results demonstrate that a single dose of DT120 ODT can produce a meaningful and durable benefit for people with depression,” Sonnenberg said. “Importantly, these results stand apart from existing treatments, representing a potentially new paradigm for the management of major depression."