MindMed Initiates Phase III Trial of MM120 (LSD) for Generalized Anxiety Disorder

Key Insights

• MindMed has launched a Phase III clinical trial for MM120, an oral tablet formulation of LSD, for treating generalized anxiety disorder (GAD).
• The trial will involve 200 participants across 20 U.S. sites, comparing MM120 to a placebo over a 12-week period, followed by a 40-week open-label extension.
• Unlike many psychedelic trials, this study isolates the drug's effects without psychotherapy, using dosing session monitors for safety and comfort.

MindMed has commenced the first Phase III clinical trial for MM120, its proprietary formulation of lysergic acid diethylamide (LSD) delivered in an oral tablet form, targeting generalized anxiety disorder (GAD). The U.S. Food and Drug Administration (FDA) previously granted MM120 breakthrough therapy designation for GAD in March.

The Phase III trial, named the Voyage study, will enroll 200 participants across 20 sites within the United States. Participants will be randomized to receive either MM120 or a placebo. The primary endpoint is the reduction in anxiety symptoms within the first 12 weeks of the study. Following this, a 40-week open-label phase will allow eligible participants to continue receiving MM120 treatment.

A notable aspect of MindMed’s approach is the exclusion of psychotherapy during the active treatment phase. Daniel R. Karlin, MindMed’s chief medical officer, stated, “We want to isolate the stand-alone effects of our investigational drug.” Instead of traditional therapy, participants will interact with a clinician serving as a “dosing session monitor” (DSM) before their dosing session. A second monitor will observe remotely via video during the session. Karlin explained that the DSM's role is to be unintrusive while ensuring participant safety through vital sign monitoring and providing assistance for basic needs.

Prior Clinical Evidence

MindMed has previously reported results from its Phase IIB study of MM120. The study indicated that individuals with GAD who received MM120 demonstrated lower scores on anxiety scales compared to those who received a placebo. Specifically, 65% of participants in the MM120 group experienced a significant decrease in anxiety. These results have not yet been published in a peer-reviewed journal. The current Phase III trial aims to confirm these findings in a larger, more definitive study.

Generalized Anxiety Disorder (GAD)

Generalized Anxiety Disorder is a prevalent mental health condition characterized by persistent and excessive worry about various aspects of life. Current treatments include psychotherapy and medications such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). However, many patients do not achieve full remission with these treatments, highlighting the need for novel therapeutic options. Psychedelic-assisted therapies are being explored as potential alternatives for treatment-resistant anxiety disorders.