COMP360 psilocybin therapy shows potential in exploratory open-label studies for anorexia nervosa and severe treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that positive data demonstrating the potential of COMP360 psilocybin therapy in anorexia nervosa and severe treatment-resistant depression has been presented at the Society of Biological Psychiatry Annual Meeting in New Orleans, from two investigator-initiated studies.

The first study looked at the safety and efficacy of COMP360 psilocybin therapy in patients with severe treatment-resistant depression (n=12), with a single 25mg dose, and was run by Dr Scott Aaronson at Sheppard Pratt, Baltimore. All participants had tried at least five antidepressant treatments without success, prior to joining the study. The researchers found that 58.3% (n=7) of the participants had maintained response criteria, for the Montgomery-Asberg Depression Rating Scale at 12 weeks after COMP360 psilocybin administration, and a quarter had maintained remission (n=3). There was no increase in the suicidality score based on the MADRS, and no serious adverse events were reported throughout the study. The data was presented at the conference on poster F120*.

The second study investigated the safety, efficacy, and tolerability of COMP360 psilocybin therapy in patients with anorexia nervosa (n=10), with a single 25mg dose, and was conducted by Dr Walter Kaye at the University of California San Diego School of Medicine. 30% (n=3) of participants experienced clinically significant reductions in eating disorder psychopathology at the 1-month follow up, and 40% (n=4) experienced clinically significant reductions at the 3-month follow-up. Participants demonstrated statistically significant reductions in shape concerns at the 1-month follow-up (p<.05), and statistically significant reductions in eating concerns at the 3-month follow-up (p<.05). Changes in weight concerns were approaching statistical significance. COMP360 psilocybin therapy was well-tolerated and 90% of participants found the experience to be meaningful and therapeutic. No serious adverse events were reported. The data was presented at the conference on poster T142**.

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