MindMed

LSD-based treatment for generalized anxiety disorder gets breakthrough therapy status

March 12, 2024

FDA's designation was based on data from the randomized, double-blind, placebo-controlled, dose-optimization, phase 2 MMED008 study, which assessed the effect of MM120 for the treatment of anxiety symptoms in 194 patients with GAD. MM120 is a tartrate salt form of lysergide (LSD), a synthetic ergotamine that acts as a partial agonist at human serotonin-2A (5-HT2A) receptors.

Mind Medicine, Inc. says the agency also considered the significant unmet medical need in the treatment of GAD, especially in patients who don't respond to or tolerate currently available medications.

MindMed had previously announced rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at week 4, which was the trial’s primary endpoint. MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention.

Initial clinical data from the phase 2b study showed that a single oral administration of MM120 100 µg met its key secondary endpoint and maintained a clinically and statistically significant HAM-A reduction compared to placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company says it plans to hold an end-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate its Phase 3 clinical program in the second half of 2024.

Key takeaways from phase 2b MMED008 study

• MM120 100 µg – the dose with optimal clinical activity observed in the trial – demonstrated a 7.7-point improvement over placebo at week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.
• Among participants who received MM120 100 mcg, Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (p<0.004).
• This clinical response was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between weeks 4 and 12.
• MM120 was generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug.
• The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.

Source:

(2024, March 7). MindMed. News Release. MindMed receives FDA breakthrough therapy designation and announces positive 12-week durability data from phase 2b study of MM120 for generalized anxiety disorder. https://ir.mindmed.co/news-events/press-releases/detail/137/mindmed-receives-fda-breakthrough-therapy-designation-and-announces-positive-12-week-durability-data-from-phase-2b-study-of-mm120-for-generalized-anxiety-disorder