DT120 for Generalized Anxiety Disorder: Findings From Phase 2b and Phase III Trials

In this video overview, Lori Davis, MD, from the University of Alabama at Birmingham discusses treatment of generalized anxiety disorder and the limitations of current approaches. She describes generalized anxiety disorder as a very common problem, notes that first-line treatments may produce inadequate response, and says remission is often unachievable for most patients with generalized anxiety disorder.

Davis then reviews DT120, which she describes as an oral disintegrating tablet of medical-grade formulation of lysergide, or LSD. She states that it acts on the serotonin 2A receptor as a partial agonist, and contrasts that with antidepressants, which she says are 5-HT2A antagonists. She summarizes three DT120 trials, including a phase 2b dose-finding randomized controlled trial that has been peer-reviewed and published, and two phase III randomized controlled trials of the 100 microgram target dose versus placebo in patients with anxiety, one presented at a conference and not yet peer-reviewed, and the second disclosed in a detailed press release.

In describing the results, Davis says the mean difference in the Hamilton Anxiety Scale was five points across all three trials, and that response and remission were more common with the 100 microgram dose than with placebo, with differences sustained through the 12-week follow-up period. She also reviews safety findings across the program, noting that nearly everyone experienced some type of adverse event, especially during the dosing day session, with visual perceptual changes, nausea, and headache reported most commonly. She says these effects were usually mild to moderate, resolved by the end of the dosing day, and were not associated with serious adverse events, deaths, worsening on the suicidality scale, or suicidal behavior in any of the trials.