COMPASS Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the publication of a paper in Nature Medicine that demonstrates the potential for COMP360 psilocybin treatment in anorexia nervosa. The investigator-initiated open-label study was conducted by Drs. Walter Kaye and Stephanie Knatz Peck at the University of California San Diego School of Medicine and is believed to be the first clinical research study to report the effects of psilocybin treatment in anorexia nervosa.

The study investigated the safety, efficacy, and tolerability of a single 25mg dose of COMP360 psilocybin, with psychological support (referred to as “psilocybin therapy” in the paper), in female patients with anorexia nervosa (n=10). The results showed:

  • 40% (n=4) of participants experienced clinically significant reductions in eating disorder psychopathology at the three-month follow-up.
  • Participants demonstrated statistically significant reductions from baseline in shape concerns at the one-month follow-up (p<0.05), and weight concerns (P = 0.04, d = 0.78) at the three-month follow-up. Changes in eating concern were approaching significance at three-month follow-up
    (P = 0.051, d = 0.71).
  • Five participants demonstrated an increase in body mass index (BMI) at three-month follow-up (range, 0.4–1.2 kg/m2). Changes in BMI were not statistically significant.
  • Overall, the psilocybin experience was regarded as meaningful by participants. Ninety percent endorsed feeling more positive about life endeavors; 80% endorsed the experience as one of the top five most meaningful of their life; and 70% reported experiencing a shift in personal identity and overall quality of life.
  • COMP360 psilocybin treatment was well tolerated. All adverse events were mild and transient in nature (the most common being headache, fatigue and nausea). No serious adverse events were reported. 

The data were first presented at the Society of Biological Psychiatry Annual Meeting in New Orleans in 2022.

“People living with anorexia nervosa urgently need new options. This study shows promising preliminary evidence that COMP360 psilocybin treatment could help people living with this difficult-to-treat condition. We are now looking to investigate these findings further in our larger phase 2 study.”

Dr. Guy Goodwin, Chief Medical Officer at COMPASS Pathways

Dr. Kaye added, “Anorexia nervosa is one of biggest challenges we face in psychiatry, since there is a high risk of dying from suicide or other causes. We’re pleased to have conducted one of the first studies of psilocybin treatment in anorexia nervosa, and for our study to be published in one of the world’s leading peer-reviewed publications. We hope our preliminary research proves to be an important step in finding new and better options for patients with this difficult-to-treat condition.”

Dr. Knatz Peck concluded, “There are no proven treatments to reverse core symptoms in anorexia and even after or in spite of weight stabilization, people with anorexia often continue to suffer with debilitating psychological symptoms that place them at risk for relapse and life impairment. Our findings suggest that a subset of people experienced significant improvements in eating disorder psychopathology. Our hope is that this study provides a pathway to continue to find better ways to address the psychology of anorexia from the inside out.”

About COMPASS Pathways

COMPASS Pathways plc is a biotechnology 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 treatment, 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 U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

We have commenced a phase 3 clinical program of COMP 360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD) and anorexia nervosa.