Jason NajumMajor news in the psychedelic medicine industry as MindMed (Mind Medicine Inc.) has received FDA Breakthrough Therapy Designation for its LSD program.
The company announced the news early Thursday morning, detailing how the FDA has granted the much sought-after Breakthrough Therapy designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD).
Potential Fast Track for LSD
FDA Breakthrough Therapy Designation is awarded to selected drugs and clinical trials, with the goal of expediting the FDA approval process. It’s granted to programs that aim to treat a serious condition and have demonstrated a substantial potential improvement over available therapies. This accelerates the developmental and review process, gives access to “Fast Track” features, and provides companies with intensive guidance from FDA senior managers. If subsequent clinical trial phases are approved, Breakthrough Therapy Designation can greatly shorten the time to market.
To date, only two other programs have received FDA Breakthrough Therapy status for psychedelics: Compass Pathways and its psilocybin program for treatment-resistant depression, and MDMA-assisted therapy for PTSD.
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“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase IIb study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, CEO of MindMed, in the company’s press release (1)
Phase IIb Results Show LSD’s Efficacy
The FDA’s decision follows more positive results from the MindMed Phase IIb study, showing significant anxiety reduction 12 weeks after a single dose of LSD.
A single oral administration of MM120 (100 µg) met its key secondary endpoint and maintained a clinically and statistically significant reduction in symptoms compared to placebo at 12 weeks — with a 65% clinical response rate and 48% clinical remission rate. These results follow earlier positive data showing a response rate of 78% and 50% clinical remission rate after 4 weeks.
These results are both significantly higher than any current treatments available for generalized anxiety disorder, and the new data showing sustained remission rates after 12 weeks might have been the final evidence the FDA needed to assign this LSD program breakthrough designation.
“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. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” stated David Feifel, MD, PhD, Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute in La Jolla, California and an investigator in the MM120 study. “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.”
Moving forward, MindMed plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase III clinical program in the second half of 2024.
If successful, the upcoming Phase III trial could be the final step in getting this potentially groundbreaking medicine to patients in need.
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MindMed stock is traded on the NASDAQ (MNMD) and on the Cboe Canada (MMED). Click here for more on the company’s LSD program.
Sources
1. Mind Medicine Inc. (2024, March 7). 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
This material is not intended as a replacement or substitute for any legal or medical advice. Always consult a medical professional about your health needs. Psychedelics are widely illegal in the United States, and readers should always be informed about local, state, and federal regulations regarding psychedelics or other drugs.
Ross Dillon 
David Connell