Compass Pathways Releases Promising Findings From Phase 2 Clinical Trial of COMP360 Psilocybin With Antidepressants in Neuropsychopharmacology, a Nature Journal
Monday, July 17, 2023
COMPASS Pathways plc (Nasdaq: CMPS) has made an announcement regarding the publication of favorable data from an open-label phase 2 clinical trial in the esteemed journal Neuropsychopharmacology. The trial focused on investigating the use of COMP360 psilocybin, an experimental treatment, in combination with selective serotonin reuptake inhibitors (SSRIs) for patients with treatment-resistant depression.
The study involved 19 participants who were experiencing treatment-resistant depression. It employed a fixed-dose design where each participant received a single 25mg dose of COMP360 psilocybin alongside psychological support while continuing their SSRIs. The results, initially disclosed in December 2021, demonstrated promising outcomes.
After three weeks, 42% of participants exhibited a significant response, defined as a greater than 50% reduction in the MADRS total score from baseline. Additionally, 42% achieved remission, indicated by a MADRS total score of 10 or less. These efficacy findings closely align with the results of COMPASS's Phase 2b study of 25mg of COMP360 psilocybin in treatment-resistant depression, where patients discontinued their antidepressants before receiving COMP360 (response and remission rates of 37% and 29% respectively at week three).
The study found COMP360 psilocybin treatment to be generally well tolerated, with headache being the most commonly reported treatment-emergent adverse event. No serious adverse events were reported.
Dr. Guy Goodwin, Chief Medical Officer at COMPASS Pathways, emphasized the importance of these findings. Contrary to previous beliefs, the data suggests that SSRIs do not impede the therapeutic effects of psilocybin. Patients may potentially retain the benefits of COMP360 psilocybin treatment while continuing their SSRI antidepressant medication.
These findings have significant clinical implications as they provide patients with the choice to remain on their antidepressant medication during COMP360 psilocybin treatment, should regulatory approval be granted for the treatment of treatment-resistant depression. The ability to avoid the need for antidepressant withdrawal may be preferable for some patients and could enhance the accessibility of COMP360 psilocybin treatment.
COMP360 is COMPASS's proprietary formulation of synthetic psilocybin, administered alongside psychological support. Currently, COMPASS is conducting the largest-ever phase 3 clinical program of COMP360 psilocybin treatment for treatment-resistant depression. This program builds upon positive results from COMPASS's phase 2b trial, which were previously published in the New England Journal of Medicine.
