Groundbreaking Study: LSD Tartrate Reduces Anxiety Effectively, Says MindMed

Clinical-stage psychedelics biotech Mind Medicine (MindMed) MNMD has published new positive topline results from its Phase 2b study on a single dose of MM-120 (LSD tartrate,) with no additional therapeutic intervention, in Generalized Anxiety Disorder (GAD.) 

MM-120 is the company’s tartrate salt form of lysergide, a synthetic tryptamine within the “classic” group of psychedelics that acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. 

The trial-targeted condition, GAD, is an underdiagnosed brain health disorder manifesting in fear, persistent anxiety and a constant feeling of being overwhelmed. It affects around 10% (or 20 million) of U.S. adults. 

MindMed reported that the clinical trial met its primary endpoint, with MM-120 demonstrating “statistically significant and clinically meaningful” dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) vs. placebo at week 4.

Study And Results

MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study.

The 198 enrolled participants presented severe GAD symptoms (average baseline HAM-A scores of 30). They all received a single MM-120 administration at a dose of 25, 50, 100 or 200 µg (micrograms) or placebo, in a monitored clinical setting, with no additional therapeutic intervention. 

The trial’s full analysis set finally included 194 subjects, which had at least one valid post-baseline HAM-A score. The primary topline results show:

• The 100 µg dose achieved the highest level of clinical activity, demonstrating a 7.6-point reduction vs. placebo at week 4. Additionally, the average improvement of 4.8 to 2.4 in the Clinical Global Impressions - Severity (CGI-S) scores represent “a two-category shift,” from "markedly ill" to "borderline ill" at week 4.

• Clinical activity following the 100 µg dose showed to be “rapid and durable,” beginning on day 2 and continuing through week 4, with no loss of activity observed on either HAM-A or CGI-S.

• MM-120 was generally well tolerated, with mild-to-moderate transient adverse events consistent with MM-120’s pharmacodynamic effects. The overall four-week trial completion rate was around 90%, and 97.5% in the high-dose groups. No participants in the high-dose groups discontinued treatment due to an adverse event. 

• Most common adverse events (at least 10% incidence in the high-dose groups) occurred on the dosing day and included illusion, hallucinations, euphoric mood, anxiety, thinking abnormal, headache, paraesthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.

Additional secondary and exploratory endpoints: 

• 78% of participants held a clinical response (50% or greater improvement in HAM-A) at week 4 after MM-120 (100 µg or 200 µg) administration, vs. 31% of the placebo participants. 

• 50% of participants treated with MM-120 100 µg achieved clinical remission (HAM-A ≤ 7) at week 4. 

• CGI-S scores demonstrated a statistically significant and clinically meaningful improvement compared to placebo in the 100 µg and 200 µg dose groups, observed as early as the day after treatment through week 4.

MindMed expects the new results will support the start of a Phase 3 program on MM-120 for GAD in 2024, for which it plans to hold an end-of-Phase 2 meeting with the FDA before mid-year.

Additionally, MindMed would unravel further topline 12-week data from the Phase 2b study in Q1 2024, presenting full results at a scientific meeting next year.

See MindMed’s latest results presentation for investors.

Photo: Benzinga edit with photo by Kat Smith on Pexels and Jü on Wikipedia.