Atai Life Sciences launches Phase 1 clinical trial of MDMA derivative

A growing number of companies have launched clinical trials for methyl​enedioxy​methamphetamine (MDMA) and its derivatives.

The most recent is Atai Life Sciences, which saw its share price surge 7.71% in mid-day trading to $3.38 after announcing it had launched a Phase 1 study of an MDMA derivative, EMP-01. The study will focus on post-traumatic stress disorder (PTSD).

Last week, MindMed (Nasdaq: MNMD) announced that it had launched a Phase 1 study investigating MDMA-like substances in healthy volunteers.

Potential for PTSD and beyond

In 2020, Multidisciplinary Association for Psychedelic Studies (MAPS) completed a Phase 3 study of MDMA-assisted psychotherapy focused on PTSD. In addition, MAPS has Phase 2 studies underway for eating disorders, anxiety associated with a life-threatening illness and social anxiety in autism.

FDA has granted Breakthrough Therapy Designation to MAPS to test MDMA in PTSD.

Other companies investigating MDMA inclu…

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MindMed announces Phase 1 study of MDMA-like substances

On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers. 

MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early evidence suggests that its MM-402 MDMA-based drug candidate can reduce social impairment. 

Like LSD, MDMA (methylenedioxy-methamphetamine) is a Schedule I drug. While the U.S. government outlawed LSD in 1968, MDMA was banned in 1985. 

The FDA, however, is purportedly considering approving MDMA as a treatment for post-traumatic stress disorder in the coming years. 

Matthias Liechti, principal investigator of the Phase 1 study on MDMA-like substances on behalf of MindMed, noted that the amphetamines MDMA and methylenedioxyamphetamine (MDA) can have mixed subjective effects — especially at the onset of response…

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LSD-assisted therapy resulted in durable anxiety improvement in Phase 2 study

[Image courtesy of PubChem]

A randomized placebo-controlled Phase 2 study found that lysergic acid diethylamide (LSD)–assisted therapy yielded significant reductions in anxiety and depression symptoms for up to 16 weeks.

The data from the study was recently published in the peer-reviewed Biological Psychiatry.

Researchers at the University Hospital Basel (UHB) conducted the investigator-initiated study, which involved 42 patients.

While there was a substantial amount of research on LSD-assisted therapy in the 1950s and 1960s, psilocybin has emerged as a more popular compound for psychedelic-based therapy in recent years.

In the data published in Biological Psychiatry, researchers used Spielberger’s State-Trait Anxiety Inventory–Global (STAI-G) score and the HAM-D-21 (Hamilton Depression Rating Scale) to quantify anxiety and depression, respectively. Investigators also used the Beck Depressio…

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MindMed launches Phase 2b to study LSD in generalized anxiety disorder

Psychedelic medicine firm MindMed (OTCMKTS:MMDCF) has dosed the first patient in a Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD).

The study will test the potential of LSD to treat general anxiety disorder (GAD), which affects about 3% of the population.

While LSD emerged as the definitive psychedelic compound of the 1960s, psilocybin has more recently emerged as a more popular recent focus of clinical trials. LSD arguably has seen more cultural backlash than psilocybin.

Unravelling psychedelic mysteries

Evidence is mixed regarding LSD’s potential to treat mood disorders. Some LSD users report obtaining life-changing insights from their experiences. For instance, the actor Cary Grant reported experiencing an “immeasurably beneficial cleansing of so many needless fears and guilts” after ingesting LSD an estimated 100 times in a therapeutic setting from 1958 to 1961. Conve…

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As interest in psychedelic medicine grows, Big Pharma sits on the sidelines

Image by Ben Johnson from Pixabay

While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building. 

Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methyl​enedioxy​methamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded that MDMA yielded a larger effect size than antidepressants Zoloft (sertraline) and Paxil (paroxetine).

The FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD in 2017. Approval could come in 2023, according to The New York Times. 

[Related: Debate series considers the therapeutic promise and pitfalls of psychedelics]

Last month, NEJM summarized the results of a Phase 2 study that found that psil…

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