Definium Therapeutics announced positive topline results today from its phase 3 Emerge study of DT120 orally disintegrating tablet (ODT) in major depressive disorder (MDD).
The Emerge study enrolled 149 participants aged 18 to 74 years across 20 sites with a DSM-5-confirmed diagnosis of MDD, a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26, and a Clinical Global Impression–Severity (CGI-S) score of at least 4 at screening and baseline. In the trial, DT120 meet its primary endpoint of change from baseline in MADRS total score at week 6 versus placebo.
DT120 is a lysergamide compound — an LSD derivative — administered as a single 100 µg orally disintegrating tablet, which sets it apart from every conventional antidepressant on the market. The idea is that one dose drives a sustained therapeutic response, rather than daily pill-taking for months or years.
MindMed rebranded as Definium earlier this year. The company dosed the first patient in its second phase 3 study, Ascend, in May, so today's readout puts both pivotal studies in motion simultaneously heading toward an NDA package.