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

Positive early signals seenin two investigator-initiated studiespresented
at the Society of Biological Psychiatry Annual Meeting in New Orleans

London, UK - 3 May 2022

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), 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 (MADRS) 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**.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, "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."

^{*An Open Label Study of the Safety and Efficacy of COMP360 in Participants With Severe Treatment-Resistant Depression (P-TRD); Scott T. Aaronson, M.D., Tammy Miller, PsyD., MacKenzie Forbes, M.S., Samuel Rudow B.S., and Audrey Shoultz, B.S. Sheppard Pratt, Baltimore, Maryland; Trisha Suppes, M.D., PhD., Stanford University School of Medicine, VA Palo Alto Health Care System, Palo Alto, CA 94304
**The Safety, Efficacy, and Tolerability of Psilocybin in Participants with Anorexia Nervosa; Stephanie Knatz Peck PhD, Samantha Shao BS, Susan Murray PhD, Walter H. Kaye MD, University of California San Diego School of Medicine, Department of Psychiatry}

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