Definium Therapeutics (formerly MindMed) announced positive topline results from Voyage, its first phase 3 study of DT120 orally disintegrating tablet (ODT) 100 µg in adults with generalized anxiety disorder (GAD).
Voyage met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at week 12. The study enrolled 214 participants aged 18 to 74 years across approximately 35 sites in the U.S. with a DSM-5-confirmed diagnosis of GAD.
“Despite the burden of the disorder, the last new FDA-approved treatment for this condition was nearly two decades ago, and many of the patients I see have not found relief despite trying multiple therapies,” said Brian Barnett, MD, Vice Chair of Psychiatry at Cleveland Clinic, and a Voyage principal investigator. “If approved, it could give patients and their physicians a treatment option that works through an entirely different mechanism than anything currently used in clinical practice.”
T120 ODT is an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of LSD.
The results mark the company’s second positive DT120 ODT phase 3 readout, following the positive Emerge results in major depressive disorder announced in June.