COMPASS Pathways launches phase II clinical trial of psilocybin therapy in anorexia nervosa

COMPASS Pathways plc (Nasdaq: CMPS), 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. Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating Disorder Examination 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.”  

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.

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com