Magic Mushrooms to Treat Anorexia? All About Compass' Novel Phase 2 Trial Of Psychedelic's Main Compound

Psychedelics mental healthcare company Compass Pathways PLC. CMPS has launched a phase 2 clinical study testing the efficacy of psilocybin with psychological support in people with anorexia nervosa.

The trial will compare the effects of 25 mg and 1 mg of COMP360 (Compass' proprietary version of psilocybin) in 60 participants across four research institutes in the UK and US: King's College London, Columbia University Irving Medical Center, University of California San Diego School of Medicine and Sheppard Pratt. 

Participant eligibility will be set for either the restrictive or binge-purge subtypes of anorexia nervosa (mild to severe), on patients with a history of disordered eating of at least three years before entering the study who have tried at least one previous treatment in the past three years.

Patients will be randomized in a 2:1 ratio to receive a single administration with either COMP360 25 mg or COMP360 1 mg. They will then be followed regularly for a period of 12 weeks, in which changes in symptoms after the therapy will be measured using the Eating Disorder Examination (EDE) interview and other measures like self-reported questionnaires.

The trial’s primary endpoint is change from the baseline in the EDE global score to week 4 after administration of COMP360 therapy, while safety assessments will also be carried out to monitor physical and laboratory values and suicidality.

Further details: this will constitute the first study to use COMPASS’ myPathfinder, a digital application for supporting patients throughout their psilocybin therapy journey. The app will be optional for participants to use and, if their consent were granted, it would collect real-world data for research on treatment responsiveness.

Back in May, the company announced positive early signals from an open-label investigator-initiated study with COMP360 psilocybin therapy, conducted by professor of psychiatry at the University of California San Diego Dr. Walter Kaye. 

In Dr. Kaye’s words: “Anorexia nervosa is one of the most difficult to treat conditions we face in psychiatry, with the highest suicide rate of any mental health challenge.” He further added that “research and progress are urgently needed, and this phase II study represents another important step forward.”  

On his behalf, COMPASS chief medical officer Dr. Guy Goodwin stated: “There are no approved pharmacological treatment options for people living with anorexia nervosa, and we are determined to change this.” 

More On COMPASS And COMP360

COMPASS aims at developing a new model of psilocybin therapy which includes proprietary synthetic psilocybin and psychological support. 

COMP360 has been designated a “breakthrough therapy” by the FDA for treatment-resistant depression (TRD). The company has already completed a phase 2b clinical trial of psilocybin therapy for depression in 22 sites across Europe and North America in what constituted the largest randomized, controlled, double-blind psilocybin therapy clinical trial ever conducted.

Results from that study showed a statistically significant and clinically relevant improvement in the severity of depressive symptom after three weeks for patients who received a single high dose of COMP360 together with therapy. 

The company is currently also running a phase 2 clinical trial of their psilocybin therapy for PTSD. 

Photo by Sasha Freemind on Unsplash