Compass Pathways has reported positive data from an exploratory Phase II trial of COMP360 psilocybin alongside daily selective serotonin reuptake inhibitors (SSRIs) for treatment-resistant depression (TRD).
With a fixed-dose design, the open-label study assessed the safety and efficacy of a single 25mg COMP360 dose along with psychological support, in addition to an SSRI.
A total of 19 participants experiencing treatment-resistant depression were enrolled in the study.
At week three, 42% of participants showed a response (a greater than 50% reduction from baseline in MADRS total score1) and remission (MADRS total score of ten or less).
Efficacy findings in the trial were also similar to a Phase IIb study of the single dose of 25mg COMP360 psilocybin. Patients in the Phase IIb study were withdrawn from their antidepressants before receiving COMP360.
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Treatment with COMP360 was well tolerated with no serious adverse events reported.
COMPASS Pathways chief medical officer Dr Guy Goodwin said: “It has long been thought that SSRIs could interfere with the potential therapeutic effect of psilocybin.
“This data is exciting because it provides a preliminary signal that this is not the case and that patients could remain on their SSRI antidepressant medication and experience the same effect from COMP360 psilocybin treatment as people who are not on SSRIs.
“This could have important clinical implications for patient choice if COMP360 psilocybin treatment receives regulatory approval for treatment-resistant depression.”
A Phase III clinical programme of COMP360 is currently ongoing and is said to be the largest clinical trial ever conducted.
The company is also planning to conduct Phase II studies of COMP360 in treating anorexia nervosa and post-traumatic stress disorder.