Mental healthcare company Compass Pathways has reported positive results from a Phase I trial evaluating the safety of COMP360 (psilocybin) for the treatment of patients with depression.
The company noted that psilocybin, which is an active ingredient in so-called ‘magic mushrooms’, was well-tolerated when given to healthy adult volunteers with support from specially trained therapists in the randomised placebo-controlled trial by King’s College London.
For the double-blind, placebo-controlled study, a total of 89 healthy volunteers were randomised in a 1:1:1 ratio to receive 10mg psilocybin, 25mg psilocybin, or placebo, with 1:1 support from a trained assisting therapist.
With up to six participants per session, 25 dosing sessions were completed during the study, which involved a follow-up period of two weeks.
The study examined the effects of 10mg and 25mg doses of psilocybin compared to placebo in healthy volunteers and reported no serious adverse events.
The majority of adverse events seen with the doses of psilocybin were of the expected psychedelic nature.
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Furthermore, the trial demonstrated the feasibility of administering the ingredient in a controlled setting to healthy participants with 1:1 therapist support in six sessions.
Compass Pathways chief innovation officer and co-founder Dr Ekaterina Malievskaia said: “This study is part of our overall clinical development programme in treatment-resistant depression. We wanted to look at the safety and tolerability profile of our psilocybin, and to look at the feasibility of a model where up to six 1:1 sessions are held at the same time.
“We are focused on getting psilocybin therapy safely to as many patients who would benefit from it as possible.”
Compass received FDA Breakthrough Therapy designation for its programme of psilocybin therapy in treatment-resistant depression last year and is currently conducting a Phase IIb study across Europe and North America in 216 patients with depression.