FDA Grants Breakthrough Therapy Designation to LSD-Based Treatment for Generalized Anxiety Disorder

Drug Topics JournalDrug Topics April 2024
Volume 168
Issue 03

Mind Medicine’s lysergide d-tartrate (MM120) demonstrated statistically significant and clinically meaningful improvements in anxiety symptoms in a phase 2b study.

Mind Medicine has received breakthrough therapy designation from the FDA for its lysergide d-tartrate (MM120) therapy to treat generalized anxiety disorder, the biopharmaceutical company announced in a press release.1 The company also announced positive 12-week durability data from a phase 2b study.

FDA sign on paper / Araki Illustrations - stock.adobe.com

FDA sign on paper / Araki Illustrations - stock.adobe.com

MM120 is a tartrate salt form of lysergide, a semi-synthetic hallucinogen commonly known as LSD. The breakthrough therapy designation was granted based on data from the MMED008 study (NCT05407064), a phase 2b trial of MM120 that demonstrated statistically significant and clinically meaningful improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo.

About MMED008

Trial Name: A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

ClinicalTrials.gov Identifier: NCT05407064

Sponsor: Mind Medicine

Summary: This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety,” David Feifel, MD, PhD, an investigator in the study, said in a release.1 “That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable. These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.”

The phase 2b trial was a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study to assess the effect of 4 doses of MM120 for the treatment of anxiety symptoms. The study included 194 adult participants between the ages of 18 and 74 who had at least one valid post-baseline HAM-A score. The participants were randomly assigned to receive either 25 µg, 50 µg, 100 µg or 200 µg of MM120 or placebo.

MM120 met both its primary and secondary endpoints. A 100 µg achieved the highest level of clinical activity and demonstrated a 7.6-point reduction in HAM-A scores compared to placebo at week 4. The reduction was rapid and durable on day 2, lasting through week 4 with no loss of activity observed.2 The 100 µg dose also demonstrated a 7.7-point reduction in HAM-A scores at week 12, with a sustained 65% clinical response rate and 48% clinical remission rate.1

READ MORE: 2024 Pharmacy Forecast: A Focus on Mental Health

The study also demonstrated that MM120 was generally well-tolerated, with most adverse events rated as mild to moderate, transient and occurring on dosing day. The most common adverse events included hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, and feeling abnormal—all of which are consistent with expected acute effects of the drug.

“As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy,” Reid Robison, MD, an investigator in the study, said in a release.1 “It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.”

Generalized anxiety disorder impacts an estimated 2.7% of adults in the US, according to data from the National Institutes of Mental Health.3 The disorder is characterized by excessive anxiety about events or activities on most days for at least 6 months. It can often cause severe impairment in social and occupational functioning.

Mind Medicine said that it plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024. The company also noted that it intends to begin a phase 3 clinical trial of MM120 in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, CEO and director of Mind Medicine, said in a release.1 “We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”

READ MORE: Mental and Behavioral Health Resource Center

1. MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase 2B Study of MM120 for Generalized Anxiety Disorder. News Release. MindMed. March 7, 2024. Accessed March 7, 2024. 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
2. MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder. News Release. MindMed. December 14, 2023. Accessed March 7, 2024. https://ir.mindmed.co/news-events/press-releases/detail/131/mindmed-announces-positive-topline-results-from-phase-2b-trial-of-mm-120-in-generalized-anxiety-disorder
3. Generalized Anxiety Disorder. Report. NIH. Accessed March 7, 2024. https://www.nimh.nih.gov/health/statistics/generalized-anxiety-disorder
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