lysergic acid diethylamide (MM-120) / Mindmed, University Hospital Basel, Maastricht University Medical Centre - LARVOL DELTA

Program Updates and Anticipated Milestones (Businesswire) - "Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the treatment of GAD. Voyage is expected to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. Topline data from the 12-week double-blind period (Part A) is anticipated in the first half of 2026; Enrollment is on track in the second Phase 3 Panorama study of MM120 ODT for the treatment of GAD. Panorama is expected to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo) in the U.S. and Europe. Topline data from the 12-week double-blind period (Part A) is anticipated in the second half of 2026....Topline data from the 12-week double-blinded period (Part A) is anticipated in the second half of 2026. The Company expects to conduct a second Phase 3 registrational study in MDD, with the study design and timing to be informed by the progress of Emerge..."

Enrollment status • New P3 trial • P3 data: top line • General Anxiety Disorder • Major Depressive Disorder

Clinical Trial Participant and Clinician Experience in a Phase 2 (US-only) Trial of MM120 for Generalized Anxiety Disorder (ISPOR 2025) - "This research outlines a successful strategy for soliciting input regarding clinical trial participant experiences. Projective techniques and visual stimuli worked well to gain a holistic picture of the participant's experience, including difficult-to-quantify emotional experiences. These insights may provide practical solutions to improving psychedelic clinical trials."

Clinical • P2 data • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Contextual and experiential aspects of the psychedelic experience predicting improvement in subjective wellbeing: results from a Norwegian internet convenience sample. (PubMed, Front Pharmacol) - "This relationship seems dependent upon various experiential aspects of acute subjective drug effects. These findings should be viewed as hypothesis-generating rather than confirmatory due to the study's limitations."

Journal

A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge) (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

MindMed Announces First Patient Dosed in Phase 3 Emerge Study of MM120 in Major Depressive Disorder (MDD) (Businesswire) - "Mind Medicine...announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD....Topline data from the 12-week double-blind period anticipated in the second half of 2026."

P3 data: top line • Trial status • Major Depressive Disorder

Motivation and retrospective appraisal of psychedelic study participation: a qualitative study in healthy volunteers. (PubMed, Psychopharmacology (Berl)) - "This paper identified four pivotal factors to be considered for psychedelic study experiences: (1) a secure interpersonal relationship, (2) an aesthetically pleasing environment, (3) access to nature, and (4) the use of music. This analysis reveals subjective views of volunteers in psychedelic Phase-I trials and may improve research standards."

Clinical • Journal • Retrospective data • CNS Disorders

Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. (PubMed, JAMA Psychiatry) - P2 | "Microdosing psychedelics, including lysergic acid diethylamide (LSD), has gained attention for its potential benefits in several psychiatric disorders, including attention-deficit/hyperactivity disorder (ADHD)...In this randomized clinical trial, repeated low-dose LSD administration was safe in an outpatient setting, but it was not more efficacious than placebo in reducing ADHD symptoms. ClinicalTrials.gov Identifier: NCT05200936."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Psychiatry

MindMed Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Updates (Businesswire) - "First Patients Dosed in Phase 3 Voyage and Panorama studies of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD); 12-week topline data anticipated in 1H 2026 for Voyage and 2H 2026 for Panorama...On track to initiate Emerge, the first Phase 3 study of MM120 ODT for the treatment of MDD in the first half of 2025. Emerge is expected to enroll 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo). Topline data from the 12-week double-blinded period (Part A) is anticipated in the second half of 2026."

New P3 trial • P3 data: top line • General Anxiety Disorder • Major Depressive Disorder

Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo Pre-Administration in a Randomized, Double-Blind, Cross-Over Phase I Trial. (PubMed, Clin Pharmacol Ther) - "Psychedelics, such as psilocybin and lysergic acid diethylamide (LSD), are being investigated for the treatment of depressive and anxiety disorders, for which concomitant treatment with selective serotonin reuptake inhibitors (SSRIs) is prevalent. The pharmacokinetic and pharmacodynamic interactions indicate that no dose adjustment of LSD seems necessary in the presence of an SSRI that inhibits CYP2D6. For SSRIs that do not relevantly inhibit CYP2D6, a dose increase of LSD might be appropriate, but due to lacking data and potential other pharmacokinetic interactions with these compounds, no definitive dose recommendation can be made."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Mood Disorders • Psychiatry • CYP2D6

Treatment of neuropathic pain with repeated low-dose MDMA: a case report. (PubMed, Front Psychiatry) - "A 64-year-old male patient who suffered from traumatic life experiences and neuropathic pain after oncological chemotherapy was treated with medium to high doses of lysergic acid diethylamide (LSD) and high doses and microdoses of methylenedioxymethamphetamine (MDMA)...This case documents benefits of low doses of MDMA for the treatment of a pain disorder. Further research is needed on effects of MDMA on pain."

Journal • Neuralgia • Pain

Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Chronic Cluster Headache • Pain

Panorama: A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Mind Medicine, Inc. | Trial completion date: Jun 2027 ➔ Nov 2026 | Trial primary completion date: Dec 2026 ➔ May 2026

Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

LPC: Lysergic Acid Diethylamide (LSD) in Palliative Care (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Trial completion date: Sep 2027 ➔ May 2028

Trial completion date • CNS Disorders • Depression • Mood Disorders • Pain • Palliative care • Psychiatry

MindMed Announces First Patient Dosed in Phase 3 Voyage Study of MM120 in Generalized Anxiety Disorder (GAD) (MindMed Press Release) - "Mind Medicine...announced that the first patient has been dosed in its Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of GAD. Voyage is the first of two Phase 3 studies in GAD evaluating the efficacy and safety of MM120 ODT versus placebo and is expected to enroll approximately 200 participants in the United States. The Panorama study, the second Phase 3 trial, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025...Based on significant unmet medical needs and promising phase 2b results, the U.S. FDA has granted Breakthrough Therapy Designation for the MM120 programme in GAD...MindMed plans to expand its clinical development program with the Panorama study in the US and Europe, starting in the first half of 2025."

Breakthrough therapy • New P3 trial • Trial status • General Anxiety Disorder

Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response. (PubMed, J Psychopharmacol) - "This study compared the subjective effects of lysergic acid diethylamide (LSD) and psilocybin between patients undergoing PAT and healthy volunteers...Patients may experience more challenging psychedelic effects and reduced ego dissolution. Hourly assessment of drug effects may predict clinical outcomes better than retrospectively assessed mystical experiences, and the impact of relaxation during PAT should be investigated further."

Clinical • Journal • CNS Disorders • Depression • Psychiatry

An open-label prospective 12-month follow-up of lysergic acid diethylamide-assisted therapy in patients with anxiety (ECNP 2024) - "Mystical-type experiences (MEQ30 total score) correlated significantly with reductions in anxiety on the STAI-G (p<0.05) and with positive changes on the PEQ (p<0.05 and p<0.01 for positive attitudes about life and/or self and positive mood changes, respectively). Conclusion Patients reported sustained long-term effects of LSD-assisted therapy in anxiety disorders, attributed positive long-term effects to the LSD experiences, and showed normalization of the personality traits neuroticism and extraversion."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Safety pharmacology of acute mescaline administration in healthy participants (ECNP 2024) - "Despite its long history, modern studies focus mainly on lysergic acid diethylamide (LSD) and psilocybin and their potential in psychotherapy [1, 2]... These findings suggest that single-dose administration of mescaline up to 800 mg were safe regarding psychological and physiological harm in a controlled clinical setting. Acute subjective effects were mainly positive, transient anxiety and "bad drug effects" occurred, but rather with doses higher than mescaline 400 mg. Cardiovascular stimulation induced by mescaline were mild."

Clinical • CNS Disorders • Mood Disorders • Psychiatry

Oral LSD base and tartrate bioequivalence and absolute bioavailability in healthy participants (ECNP 2024) - "Background: Lysergic acid diethylamide (LSD) is currently being investigated as novel treatment for various psychiatric and neurological illnesses... LSD base and tartrate are bioequivalent when dosed orally at same base doses and share a comparable pharmacodynamic profile. The oral BA of LSD is 80% of an IV administration. Dosing with LSD in research with LSD base and LSD tartrate can be considered equivalent."

Clinical • CNS Disorders • Mood Disorders • Psychiatry

Functional and sexual disability, and quality of life after one dose of MM120 (lysergide) in adults with generalized anxiety disorder (ECNP 2024) - "Overall, MM120 demonstrated rapid and durable improvements in anxiety, and demonstrated clinically meaningful improvements in FD, SD and QoL, which represents a significant distinction from existing standard of care treatments. Mind Medicine (MindMed), Inc. supported this study."

Clinical • HEOR • CNS Disorders • General Anxiety Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder

Rapid and durable response to a single dose of MM120 (Lysergide) in generalized anxiety disorder: A dose-optimization study (ECNP 2024) - "These findings suggest a rapid, robust, and durable clinical response to MM120 in patients with moderate-to-severe GAD with no identified safety concerns. Mind Medicine (MindMed), Inc. supported this study."

CNS Disorders • Depression • General Anxiety Disorder • Mental Retardation • Mood Disorders • Pain • Psychiatry

Large-scale brain connectivity changes following the administration of lysergic acid diethylamide, d-amphetamine, and 3,4-methylenedioxyamphetamine. (PubMed, Mol Psychiatry) - P1 | "Finally, while all substances decreased global connectivity in visual areas, compared to placebo, LSD specifically increased global connectivity in the basal ganglia and thalamus. These findings advance our understanding of the distinctive neurobiological effects of psychedelics, prompting further exploration of their therapeutic potential."

Journal • CNS Disorders • Mental Retardation • Psychiatry

Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases. (PubMed, Cochrane Database Syst Rev) - "Implications for practice Psychedelic-assisted therapy with classical psychedelics (psilocybin, LSD) may be effective for treating anxiety, depression, and possibly existential distress, in people facing a life-threatening disease. Psychedelic-assisted therapy seemed to be well tolerated, with no treatment-emergent serious adverse events reported in the studies included in this review. However, the certainty of evidence is low to very low, which means that we cannot be sure about these results, and they might be changed by future research. At the time of this review (2024), psychedelic drugs are illegal in many countries. Implications for research The risk of bias due to 'unblinding' (participants being aware of which intervention they are receiving) could be reduced by measuring expectation bias, checking blinding has been maintained before cross-over, and using active placebos. More studies with larger sample sizes are needed to reduce imprecision. As the US..."

Clinical • Journal • Review • CNS Disorders • Depression • Mood Disorders • Oncology • Pain • Psychiatry • Xerostomia

Pharmacological and non-pharmacological predictors of the LSD experience in healthy participants. (PubMed, Transl Psychiatry) - "The pharmacodynamic effects of lysergic acid diethylamide (LSD) are diverse and different in different individuals...In summary, besides the amount of drug consumed, non-pharmacological factors such as personal traits and current mood also significantly predicted the subjective drug experience. Sex and body weight were not significant factors in influencing the drug experience."

Clinical • Journal • Mood Disorders • Psychiatry