Definium Therapeutics (formerly MindMed) announced positive topline results from Panorama, the company’s second phase 3 study of DT120 orally disintegrating tablet (ODT) in adults with generalized anxiety disorder (GAD).
Panorama met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) total score at week 12. The Least Squares mean change from baseline in HAM-A total score at week 12 in participants who received DT120 ODT 100 µg was -9.8 compared with -4.7 for participants who received placebo.
“Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting,” said Definium CEO Rob Barrow.
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.
The results mark the company’s third positive DT120 ODT phase 3 readout. In August, Definium announced positive topline results from Voyage, its first phase 3 study of DT120 100 µg in adults with GAD. In June, the company shared positive topline results from its phase 3 Emerge study of DT120 in major depressive disorder (MDD).