MindMed Reaches Phase 3 in Study of Psychedelic MM120 for Generalized Anxiety Disorder

The first patient has been dosed in phase 3 of the MindMed trial of lysergic acid-diethylamide (LSD) for generalized anxiety disorder (GAD). MindMed's chief medical officer, Daniel R. Karlin, MD, MA, spoke with Psychiatric Times about the news and what it means for the future of psychiatry.

The study design is 100 mcg of MM120 vs placebo in a 12 week, randomized, double blind, placebo controlled, primary period, according to Karlin. After the first 12 weeks, a 40 week extension phase will offer the opportunity for patients to receive up to 4 additional doses of the 100 mcg MM120 in an open label form.

Karlin told Psychiatric Times that there has not been much innovation in pharmacotherapy for GAD in the last 20 years, and that phase 2 found that a single administration of MM120 led to 12 weeks of efficacy. Patient improvement was measured in phase 2 using the HAM-A scale after weeks 1 and 12.

Looking to the future of the study, Karlin said phase 3 offers the opportunity to learn how long the effect of MM120 has on patients with GAD. “Because we have this extension phase, we’ll have the opportunity to characterize a response out to a full year after treatment.” Karlin also discussed what other information the extension phase will bring in, including potential full remission within the year-long study period and characterizing both patients who experience initial positive response but do not sustain it and patients who respond only after multiple doses.

Read more about the trial here.

Dr Karlin is the chief medical officer of MindMed and a fellow of the APA.