Phase 2 clinical trial to examine efficacy of psilocybin for anorexia nervosa

COMPASS Pathways PLC has announced the launch of 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.

According to a company release, the 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. The study will be conducted at King’s College London in the U.K., Columbia University Irving Medical Center, the University of California, San Diego, School of Medicine and Sheppard Pratt in Baltimore.

“There are no approved pharmacological treatment options for people living with anorexia nervosa, and we are determined to change this,” COMPASS Pathways Chief Medical Officer Guy Goodwin, MD, said in the release. “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.”

Per the release, the study will be the first to utilize myPathfinder, COMPASS’ digital application for supporting patients throughout their COMP360 psilocybin therapy journey. The app is optional for participants, for whom it aims to provide engaging education about the therapy model, and with participant consent, also collects real-world data for research on treatment responsiveness.

Currently there are no approved pharmacological treatments for anorexia nervosa. Globally, about 2.2% of women and 0.3% of men suffer from the disorder at some point in their lives, the company said in its release.