Poster
162
(#162) MM120 (LSD) Phase 1 and Phase 2: A Detailed Safety Analysis
Psych Congress 2025
Abstract: Introduction
MM120 (lysergide; LSD D-tartrate) is under development by Mind Medicine, Inc. for generalized anxiety disorder (GAD) and major depressive disorder (MDD). A single-dose paradigm for MM120 is being evaluated as a potential treatment option with improved rapidity of onset, magnitude of efficacy, prolonged durability, and a favorable tolerability profile compared to current standard of care.
Methods
Safety data were derived from three studies (n=171 adult participants): two Phase 1 open-label, randomized, 2-period, 2-sequence, crossover studies and a multicenter, randomized, double-blind, placebo-controlled Phase 2b study. Treatment-emergent adverse events (TEAEs), vital signs, and suicidality (Columbia-Suicide Severity Rating Scale) were monitored and reported.
Results
In the Phase 1 studies, >75% of participants experienced TEAEs. Most occurred on dosing day and were consistent with the known acute pharmacodynamic profile of MM120. The most frequently reported TEAEs across the Phase 1 studies were mydriasis, visual hallucinations, euphoric mood, and illusions.
In the Phase 2b study, TEAEs occurring on the dosing day were mild to moderate and included hallucinations, illusions, euphoric mood, anxiety, mydriasis, nausea, and increases in blood pressure.
Related serious adverse events were not observed. No participants exhibited active suicidal ideation or behavior during sessions or post-treatment. Vital signs changes were not clinically significant.
Conclusion
A single administration of MM120 (n=171) was characterized by transient sensory-perceptual and physiological effects. The majority of TEAEs were rated mild to moderate. No suicidality signal was observed. These findings demonstrate a consistent safety profile across studies, supporting further clinical evaluation of MM120.
Short Description: MM120 (LSD) is under development by MindMed for GAD and MDD as a single-dose treatment. Safety data from three studies (n=171) showed transient, mild-to-moderate sensory-perceptual and physiological effects, including hallucinations, illusions, euphoric mood, and mydriasis. No related serious adverse events, suicidality signals, or clinically significant vital sign changes were observed, supporting MM120's safety profile appropriate for further clinical evaluation.
Name of Sponsoring Organization(s): Mind Medicine, Inc.
MM120 (lysergide; LSD D-tartrate) is under development by Mind Medicine, Inc. for generalized anxiety disorder (GAD) and major depressive disorder (MDD). A single-dose paradigm for MM120 is being evaluated as a potential treatment option with improved rapidity of onset, magnitude of efficacy, prolonged durability, and a favorable tolerability profile compared to current standard of care.
Methods
Safety data were derived from three studies (n=171 adult participants): two Phase 1 open-label, randomized, 2-period, 2-sequence, crossover studies and a multicenter, randomized, double-blind, placebo-controlled Phase 2b study. Treatment-emergent adverse events (TEAEs), vital signs, and suicidality (Columbia-Suicide Severity Rating Scale) were monitored and reported.
Results
In the Phase 1 studies, >75% of participants experienced TEAEs. Most occurred on dosing day and were consistent with the known acute pharmacodynamic profile of MM120. The most frequently reported TEAEs across the Phase 1 studies were mydriasis, visual hallucinations, euphoric mood, and illusions.
In the Phase 2b study, TEAEs occurring on the dosing day were mild to moderate and included hallucinations, illusions, euphoric mood, anxiety, mydriasis, nausea, and increases in blood pressure.
Related serious adverse events were not observed. No participants exhibited active suicidal ideation or behavior during sessions or post-treatment. Vital signs changes were not clinically significant.
Conclusion
A single administration of MM120 (n=171) was characterized by transient sensory-perceptual and physiological effects. The majority of TEAEs were rated mild to moderate. No suicidality signal was observed. These findings demonstrate a consistent safety profile across studies, supporting further clinical evaluation of MM120.
Short Description: MM120 (LSD) is under development by MindMed for GAD and MDD as a single-dose treatment. Safety data from three studies (n=171) showed transient, mild-to-moderate sensory-perceptual and physiological effects, including hallucinations, illusions, euphoric mood, and mydriasis. No related serious adverse events, suicidality signals, or clinically significant vital sign changes were observed, supporting MM120's safety profile appropriate for further clinical evaluation.
Name of Sponsoring Organization(s): Mind Medicine, Inc.
