LSD Therapy for Anxiety Earns FDA Breakthrough Status

MindMed, a company pioneering in psychedelic medicine, has achieved a significant landmark with its LSD-based drug, MM120, for treating generalized anxiety disorder (GAD). The U.S. Food and Drug Administration (FDA) has recognized the drug's potential by granting it a breakthrough therapy designation following positive results from a Phase IIb clinical trial.
The announcement of this FDA designation has had a substantial impact on MindMed's stock performance, with a surge of over 50% by the end of the trading day and a further 4% rise in pre-market trading.
The Phase IIb study demonstrated that MM120 not only met its primary endpoint but also exhibited a significant and lasting effect, with benefits observed up to 12 weeks post-treatment. MindMed's CEO, Robert Barrow, expressed the company's dedication to advancing MM120 as a treatment option for GAD patients, highlighting the drug's potential to fill a substantial gap in current treatment options for serious brain health disorders.
In December 2023, MindMed reported that MM120 had shown substantial improvements over a placebo on the Hamilton Anxiety rating scale, with a 100µg dose leading to a 7.7-point improvement and a statistically significant clinical response and remission rate that was maintained at week 12. Additionally, the clinical global impressions severity scores indicated a marked improvement, shifting from a state of being markedly ill to borderline ill.
The company's Chief Medical Officer, Dan Karlin, provided further insights into the Phase II success and the future prospects of psychedelic treatments in January 2024. The FDA's decision to grant the breakthrough therapy designation was influenced by the unmet medical need for GAD treatments, the positive Phase IIb data, and additional supporting research. MindMed is planning an end-of-Phase II meeting with the FDA in the first half of 2024, with Phase III trials set to commence later in the year.
Reid Robison, a psychiatrist and chief clinical officer at Numinus, who was also an investigator in the MM120 study, commended the study's design for its ability to isolate the drug's effects and expressed optimism that the results could translate into significant benefits for patients.
The progress of MindMed's MM120 underscores the growing interest and potential in the field of psychedelic medicine, offering new hope for individuals suffering from GAD and other serious brain health conditions.