The World Health Organization has estimated that the COVID-19 pandemic led to a 25% increase in cases of anxiety disorder worldwide in 2020. As the prevalence of mental and behavioral health disorders is increasing around the world, new treatment modalities are emerging to address the growing need for mental health care.
Among them is MM-120, a pharmacologically optimized form of lysergic acid diethylamide (LSD) developed by MindMed to treat generalized anxiety disorder (GAD). MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology – specifically stating, “We help patients unlock the healing power of the mind through psychedelic inspired medicines and experiential therapies.”
LSD Joins Other Psychedelic Targets
LSD was first synthesized in 1938 and its psychoactive properties were discovered in 1943. Through the 1950s and into the 1960s, LSD was used by psychiatrists as a tool in psychotherapy and researchers to study the brain. After being classified as a Schedule 1 controlled substance in the U.S. in 1968, however, research activity slowed.
A renewed interest in LSD and other psychedelics as medicine has developed in recent years, accompanied by efforts to legalize the drugs for therapeutic use. Drugs including ketamine, MDMA, psilocybin and mescaline represent a potential new tool for treating depression, PTSD, anxiety, and addiction in cases that don’t respond to other forms of treatment. One systematic review of seven studies representing a total of 130 patients showed positive outcomes treating anxiety and depression with ayahuasca, psilocybin, and LSD.
Research into LSD’s mechanism of action in the brain suggests why it may be an effective choice for treating depression. The drug plays a similar role to selective serotonin reuptake inhibitors (SSRIs), the well-known class of drugs for depression and anxiety that includes Prozac and Zoloft. Low doses of LSD increase the transmission of serotonin by desensitizing serotonin receptors.
MM-120 Enters Phase IIb
MM-120 is being evaluated in a multi-center, randomized, double-blind, placebo-controlled, dose-optimization Phase IIb study in patients with GAD. The participants receive a single dose of up to 200 µg of MM-120 or a placebo. The primary objective of the study is to examine any reduction in anxiety symptoms for up to 12 weeks after administration, compared across five treatment arms.
The company presented topline data at London’s PSYCH Symposium on May 11, 2022, to report the treatment outcomes of 46 patients who were evaluated 16 weeks after receiving either the treatment or placebo. According to MindMed’s press release, the treatment was associated with significant reductions in scores on the State Trait Anxiety Inventory. A reduction of at least 30 % was reported in 65 % of the patients who had received doses LSD, compared with 9 % of the patients who had received a placebo. Secondary outcome measures, which included improvements in Hamilton Depression Scale (HAM-D), Beck Depression Index (BDI), and several other major psychiatric symptoms (Symptom-Check-List-90-R) scores showed similarly positive results.
Matthias Liechti, co-primary investigator of the trial, commented, “While psychedelics including LSD have shown beneficial effects on reducing anxiety, there has still been a need for a deeper understanding of the mechanisms and the long-lasting effects by which psychedelics exert their therapeutic effects. Thus, we designed a robust, randomized, placebo-controlled clinical trial with a long follow-up period to extend the promising findings of previously conducted smaller, open-label trials. We are extremely encouraged by the results presented today, demonstrating the long-lasting and strong reduction in patients suffering from anxiety. We look forward to reporting additional analyses and further investigating the therapeutic potential of LSD for patients suffering from anxiety disorders.”
Other Mental Health Targets
MindMed’s psychedelic medicine clinical pipeline also includes psilocybin, MDMA and DMT – targets shared by a number of other companies and researchers. The company’s approach to mental health care calls for incorporating both psychedelic-assisted therapy and non-hallucinogenic take-home medicines. It is also funding a research and training program for clinicians to prepare psychiatrists for the eventual administration of psychedelic-assisted therapies. Treatments in the pipeline include psilocybin-assisted psychotherapy for alcohol use disorder and microdosing LSD for adult ADHD.
As research continues, LSD and other classic psychedelics (and the lab-manufactured molecules based on them) may yield the next generation of therapies for depression, anxiety and other mental health conditions, offering hope to those who have not found success with traditional therapeutics.
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