A multi-center, double-blind randomized controlled phase 2 clinical trial investigating the efficacy of COMP360 psilocybin, along with psychological support, in those with anorexia nervosa has been launched by COMPASS Pathways PLC.
COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it has launched a multi-centre, double-blind randomised controlled phase II clinical trial investigating the efficacy of COMP360 psilocybin, administered with psychological support, in people with anorexia nervosa.

The phase II clinical trial will compare the effects of 25 mg and 1 mg of investigational COMP360 psilocybin when administered with psychological support, in 60 participants with anorexia nervosa, across four world-leading 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).
Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating Disorder Examination (EDE) interview and other measures; the trial primary endpoint is change from baseline in the EDE global score at week 4 after administration of COMP360 psilocybin therapy.
Anorexia nervosa is a serious mental illness characterised by severe restriction of calorie intake and a preoccupation with weight and shape. Anorexia carries the highest mortality rate (5.86)1 of all psychiatric disorders because of medical complications and suicide;2 approximately 20-40% of deaths in anorexia nervosa are thought to result from suicide.3 Currently there are no approved pharmacological treatments. Globally, about 2.2% of women and 0.3% of men suffer from anorexia nervosa at some point in their lives.4
In May, COMPASS announced positive early signals from an exploratory, open-label investigator-initiated study conducted by Dr Walter Kaye, Professor of Psychiatry at the University of California San Diego School of Medicine Department of Psychiatry Eating Disorders Program and Principal Investigator on the phase II trial.5 Dr Kaye said: "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.
Not only can it have a huge impact on the people living with it, but also on the people closest to them. Research and progress are urgently needed; we've already seen encouraging data from an exploratory, open-label study in treating anorexia nervosa with COMP360 psilocybin therapy, and this phase II study represents another important step forward."
Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, "There are no approved pharmacological treatment options for people living with anorexia nervosa, and we are determined to change this. We are conducting this rigorous clinical trial to understand whether COMP360 psilocybin, with psychological support, could help people living with anorexia nervosa who urgently need new options."
This will be the first study to use myPathfinder, COMPASS' digital application for supporting patients throughout their COMP360 psilocybin therapy journey. The app is optional for participants in the study, providing engaging education about the therapy model, and with participant consent, collecting real-world data for research on treatment responsiveness. Learn more here.
References:
1. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies; Jon Arcelus, Alex J Mitchell, Jackie Wales, Søren Nielsen. Archives of General Psychiatry. https://pubmed.ncbi.nlm.nih.gov/21727255/. Last accessed: July 2022.
2. Rethinking Therapeutic Strategies for Anorexia Nervosa: Insights From Psychedelic Medicine and Animal Models; Claire J. Foldi, Paul Liknaitzky, Martin Williams, Brian J, Oldfield. Frontiers in Neuroscience. https://www.frontiersin.org/articles/10.3389/fnins.2020.00043/full. Last accessed: July 2022
3. Characteristics of Suicide Attempts in Anorexia and Bulimia Nervosa: A Case–Control Study; Sébastien Guillaume, Isabelle Jaussent, Emilie Olié, Catherine Genty, Jacques Bringer, Philippe Courtet, Ulrike Schmidt. PLOS ONE. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0023578. Last accessed: July 2022
4. Epidemiology of eating disorders: An update; Anna Keski-Rahkonen, Anu Raevuori, Hans Wijbrand Hoek. https://www.researchgate.net/publication/252793579_Epidemiology_of_eating_disorders_An_update. Last accessed: July 2022.