Benzinga | Jun 3, 2021 09:30AM EDT

COMPASS Pathways, Kings College London Publish Cognition Results From COMP360 Psilocybin Study In Healthy Volunteers

COMPASS Pathways plc (NASDAQ:CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has reported further results from a phase I study showing that its COMP360 psilocybin had no clinically-relevant negative effect on cognitive function, when administered to healthy adult volunteers with support from specially trained therapists.

The data (see poster) from the randomised, double-blind, placebo-controlled, phase I trial conducted at King's College London, will be presented today at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, by Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in Psychopharmacology at King's College London's Institute of Psychiatry, Psychology and Neuroscience (IoPPN). Initial results from the study were published in December 2019. The results published today present a more in-depth analysis of cognitive data and showed some trends of positive effects, but these were minor and call for further exploration in clinical populations.

The study looked at the effects of two doses of COMP360 psilocybin (10mg and 25mg) compared with placebo in 89 healthy male and female adult volunteers. The participants were randomised in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30), or placebo (n=29). The drug was administered simultaneously to up to six participants, who all received 1:1 psychological support from trained therapists throughout the session.

Aspects of cognitive function were measured using the gold standard Cambridge Neuropsychological Test Automated Battery (CANTAB), one day prior to COMP360 administration (baseline), and one week and four weeks after administration.

Key results:

* These findings suggest that single doses of COMP360 do not exert clinically-relevant, negative effects in healthy volunteers on the cognitive functions assessed

* On some of the CANTAB measures, there were trends demonstrating, on average, better cognitive performance in the COMP360 groups by week four, compared with baseline. These findings call for further investigation in clinical populations

* The small sample size, and the fact that participants were typically highly educated, limit the generalisability of results

* As reported previously, there were no serious adverse events, and COMP360 psilocybin was found to be generally safe and well-tolerated

Dr Ekaterina Malievskaia, Chief Innovation Officer and Co-founder, COMPASS Pathways, said: "This study is an important part of our clinical development programme of psilocybin therapy for treatment-resistant depression (TRD). The results are encouraging and we are looking forward to reporting data from our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) later this year."

Dr Rucker said: "This study, the largest randomised placebo-controlled trial of psilocybin to date, found that COMP360 psilocybin had no clinically-relevant negative effect on cognitive function. The results of the study are clinically reassuring and support further development of psilocybin therapy for patients with mental health conditions that have not improved with existing treatments, such as TRD."