Positive outcomes for the use of psilocybin therapy in conjunction with SSRIs have been reported from COMPASS Pathways’ Phase IIb trial.
British mental healthcare company COMPASS Pathways has reported positive results from its exploratory study of COMP360 psilocybin therapy in conjunction with SSRIs. The company has announced that the study saw comparable treatment outcomes to patients in its Phase IIb trial where patients were withdrawn from their SSRI prior to COMP360 psilocybin therapy.
The single-arm, open-label study involved 19 patients from clinical sites in Ireland and the United States taking concomitant SSRI therapy with COMP360 psilocybin therapy using a single dose of 25mg. The majority of patients enrolled in the study were female (68.4 per cent) with an average age of 42 years.
COMP360 psilocybin therapy received FDA Breakthrough Therapy designation for treatment-resistant depression (TRD) in 2018.
COMPASS Pathways’ chief medical officer, Guy Goodwin, commented: “The results of this study challenge the widely-held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin’s therapeutic effect. Our findings provide a strong signal that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressant as well as a monotherapy.
“For some patients with treatment-resistant depression, withdrawal is a difficult step even though, by definition, ‘treatment-resistant’ means that those antidepressants are not working. This is exactly why we conduct rigorous research to help guide our clinical trial design – including addressing barriers to adoption of COMP360 therapy.”
The primary endpoint was the change in baseline Montgomery–Åsberg Depression Rating Scale (MADRS) total score at three weeks, which is a questionnaire used to measure depressive episode severity in mood disorder patients.
Data from the study demonstrated that 8 of the 19 patients (42.1 per cent) responded to the therapy at week three (compared with 36.7 per cent at week three in the Phase IIb trial) and all 8 were also remitters.
COMPASS stated that the mean reduction from the baseline observed in the MADRS total score was 14.9 at week three (compared with a 12.0 mean reduction in MADRS in the phase IIb trial), and that there was a rapid response from day two to week three after COMP360 therapy, which is also consistent with the Phase IIb result.
It also noted that its COMP360 psilocybin therapy showed overall signals of improvement in most other measures including improvement in anxiety, clinician and self-rated depressive symptoms, and positive and negative affect.
25mg COMP360 psilocybin therapy was generally well-tolerated when it was administered simultaneously with the patient’s SSRI treatment and there were no treatment-emergent adverse events (TEAEs) classed as serious (life threatening, leading to disabilities, hospitalisation or in general medically significant) and no TEAEs related to suicidal ideation or behaviour or intentional self-injury.
Goodwin stated that COMPASS will be meeting with the FDA in the new year to finalise its plans for the Phase III programme, expected to begin in Q3 of 2022.
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