After a single 25mg dose of COMP360 psilocybin therapy, approximately 30% of patients with
treatment-resistant depression (TRD) were in remission at week 3
Sustained response seen through week 12 in twice the number of TRD patients that received 25mg dose vs 1mg
Phase 3 pivotal programme expected to commence in 2022
London, UK – 3 November 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 The New England Journal of Medicine (NEJM), the world’s leading peer-reviewed medical journal, has published the positive results from its phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) – the largest study of its kind.
The objective of the randomised, controlled, double-blind phase 2b study was to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. After a single 25mg dose of COMP360 psilocybin, in combination with psychological support, 29.1% of participants with TRD were in remission by week 3 (p<0.002) – this is higher than the response rates seen for equivalent lines of treatment in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study*, a large prospective clinical trial of major depressive disorder conducted to determine the effectiveness of different treatments for depression.
“The publication of our COMP360 psilocybin therapy study in the most prestigious peer-reviewed medical journal in the world is a proud moment for everyone involved,” said Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways. “We saw positive results in a particularly difficult to treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognised as a new treatment option in the future. We look forward to starting our phase 3 programme later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”
Further detail: phase 2b study synopsis
In the phase 2b trial, 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists.
- Rapid reduction in symptoms: Approximately 30% of patients in the 25mg group were in remission at week 3 (29.1%). This is higher than the response rates seen for equivalent lines of treatment in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, a large prospective clinical trial of major depressive disorder conducted to determine the effectiveness of different treatments for depression
- Patients who received a single 25mg dose of COMP360 psilocybin, in combination with psychological support, experienced a highly statistically significant, rapid reduction in symptoms of depression after three weeks: the difference between the 25mg group and 1mg group was -6.6 on the MADRS** depression scale at week 3, p<0.001
- Sustained response: Double the number of patients who received a 25mg dose had a sustained response at week 12, compared to those who received 1mg (20.3% of patients in the 25mg group vs 10.1% in the 1mg group)
- Well-tolerated: COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the most common adverse events where a dose-related increase in incidence was evident
- Safety monitoring: Suicidal ideation and intentional self-injury were seen in all treatment groups, as is common in TRD studies. Most cases occurred more than a week after the COMP360 psilocybin session. There was no mean worsening of suicidal ideation scores on the MADRS scale in any treatment group. Suicidal behaviours were reported at least one month after COMP360 administration for three non-responders in the 25mg arm
Scott Aaronson, MD, Chief Science Officer of the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Health System, and a Principal Investigator on the trial, said, “Over 100 million people around the world suffer with treatment-resistant depression, and haven’t found relief from existing therapies. With every new treatment, the chance of responding decreases significantly, and patients become even more hopeless. Yet in this study, a substantial number of patients in the 25mg group experienced improvement in their symptoms of depression, with the effects lasting for up to three months. I’m proud to have been part of this important study and to see the results recognised today by such a respected journal.”
Data from the phase 2b trial was announced in November and December 2021, and presented at the American Psychiatric Association annual meeting in New Orleans in May 2022. COMPASS Pathways presented the design of its phase 3 clinical programme on 12 October 2022 and plans to commence by the end of the year.
*Sinyor M, Schaffer A, Levitt A. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Trial: A Review. The Canadian Journal of Psychiatry. 2010;55(3):126-135. doi:10.1177/070674371005500303
**MADRS = Montgomery-Åsberg Depression Rating Scale, a diagnostic questionnaire used to measure the severity of depression. A higher score indicates more severe depression. Response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; sustained response = patients meeting the MADRS response criteria from week 3 and at all subsequent visits until week 12.