Early clinical data on psilocybin in anorexia point Compass to potential new opportunity

Compass Pathways has early evidence that its psilocybin therapy can improve outcomes in people with anorexia nervosa. Working with anorexia expert Walter Kaye, M.D., the British biotech showed 40% of subjects in the small study experienced clinically significant reductions in eating disorder psychopathology after a single dose of the active ingredient in magic mushrooms.

Psilocybin therapy has shown promise in a small clutch of psychiatric indications, perhaps most notably in the phase 2b trial of Compass’ COMP360. The case for expanding research into anorexia rests on early clinical evidence that psilocybin can help patients with anxiety and obsessive compulsive disorder, both of which are implicated in the development and maintenance of dysfunctional eating. Kaye, a researcher at the University of California, San Diego, set out to study psilocybin in anorexia in 2020.

The 10 participants in the investigator-initiated clinical trial received a single 25-mg dose of COMP360. At one month, three of the participants had experienced clinically significant reductions in eating disorder psychopathology. The number of responders increased to four by the third month. 

Compass also reported statistically significant reductions in participants' concerns about their body shape at months one and three. The trial failed to detect a change in weight concerns, although Compass said the endpoint was approaching statistical significance. Nine of the 10 subjects found the experience to be meaningful and therapeutic, and no serious adverse events were reported.

Kaye and his collaborators presented the data at the Society of Biological Psychiatry annual meeting, where other researchers shared data for COMP360 in severe treatment-resistant depression. Seven of the 12 subjects in the investigator-initiated depression trial had maintained response criteria at 12 weeks. While durability and suicidal behavior and ideation were two of the concerns identified in Compass’ phase 2b data, the latest findings showed no increase in the suicidal thoughts.

Guy Goodwin, M.D., chief medical officer at Compass, discussed the importance of the clinical trial results and their implications for the biotech's next steps in a statement. 

“These independent studies looked at two of the most challenging mental health conditions, where patients are unlikely to receive relief from current available treatments. The results provide promising preliminary evidence that COMP360 psilocybin therapy could help people living with anorexia nervosa and severe treatment-resistant depression and underlines our belief that this needs to be further investigated in larger scale clinical studies,” Goodwin said. 

Compass plans to start a phase 3 clinical trial of COMP360 in treatment-resistant depression this year.