COMPASS Pathways has launched its multi-centre, doubleblind randomised controlled Phase 2 clinical trial investigating the efficacy of its proprietary formulation of synthetic psilocybin, COMP360, in people with anorexia nervosa.
Anorexia nervosa is a serious mental illness that has one of the highest mortality rates due to medical complications and suicide. The condition affects around 2.2 per cent of women and 0.3 per cent of men across the globe, and there is currently no approved pharmacological treatments.
With a desperate need for new treatments, COMPASS Pathways will be carrying out the Phase 2 trial which will explore the efficacy of COMP360 psilocybin administered with psychological support in people with anorexia nervosa.
The trial will compare the effects of 25mg and 1mg of investigational COMP360 psilocybin with psychological support in 60 participants with the condition. It will be carried out across four world-leading research institutes in the UK and US, including King’s College London, Columbia University Irving Medical Center, University of California San Diego School of Medicine and Sheppard Pratt.
Chief Medical Officer at COMPASS Pathways, Dr Guy Goodwin, commented: “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.”
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 2 trial.
Dr Kaye commented: “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 2 study represents another important step forward.”
This study will be the first to use myPathfinder, COMPASS Pathways’ 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.
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