Each month we profile an innovative, growing company from across the Greater South East of England. Founded in 2016, London-based COMPASS Pathways’ ambition is to be a leading company in mental health innovation. Their first major initiative is developing psilocybin therapy through late-stage clinical trials in Europe and North America for patients with treatment-resistant depression. We met with Ekaterina Malievskaia, Chief Medical Officer and Co-Founder and George Goldsmith, Chairman and Co-Founder, to find out more.

Tell us about the mission of COMPASS Pathways.

K: Our mission is about access to innovation. We want to accelerate patient access to evidence-based innovation in mental health. We want to empower patients and to help them get access to the right treatments. Our first initiative is working with psilocybin, which is an active ingredient in magic mushrooms. We believe psilocybin is one of the most promising innovations for depression. Depression is one of the fastest growing health problems we face today. And there are 100 million people around the world who suffer with treatment-resistant depression and don’t respond to any existing medications.

How did COMPASS come about?

K: When my son went to college he suddenly developed severe depression. We were looking for solutions for him and we couldn’t find any viable options. Eventually I came across this promising research using psilocybin. Our backgrounds enabled us to find the research and explore different options. Depression is one of the world’s largest unmet needs; we talked to a lot of people along the way who were struggling – patients, parents, families. We started COMPASS so we could help others get access to innovation in mental health.

What’s your background?

K: I am a physician and my background is in private practice and academic medicine in public health in the US, predominately in New York. Some years ago I moved to London and I worked in medical philanthropy in public health, particularly in HIV AIDS in Africa, until we made this change and created COMPASS.

G: I trained in cognitive science and clinical psychology in the US and then realised I wanted to work on a larger scale. I became an entrepreneur in software and in 2002 I created a company called Tapestry Networks, bringing people from private sector and government together to look at effective regulation that enhances innovation, whilst supporting the public good. I worked on regulatory innovation in healthcare, as part of the European Healthcare Innovation Leadership Network, with members from nine countries in Europe and the US focussed on getting the right medicine to the right patient at the right time, and at a cost that society could afford.

Tell us about your Phase IIB trial that is taking place.

G: We are running a randomised controlled trial of psilocybin therapy, manufactured for the first time to GMP (highest manufacturing grade) standards, for treatment-resistant depression. It will be the largest clinical study of its kind and takes place in several clinical trial sites across Europe and North America. The trial takes place in a supervised setting, and each of the 216 patients will receive eye shades, a music track to ground them, and the psilocybin – it is a six-hour experience and they are accompanied by a therapist and chaperone at all times. That single treatment can act as a reset for them and could be of benefit for weeks or months after.

K: Before setting up the trial, we took scientific advice from the European Medicines Agency, with representatives from 28 member states and payers from the UK, Norway and the Netherlands, looking at the early signals. They suggested we concentrate on treatment-resistant depression as it is such an unmet need and there has been no serious innovation in this space in a long time. We have actually just received Breakthrough Therapy designation from the FDA, the US regulator – this means they believe our product may show substantial improvement over available therapy and that they will support our clinical development programme to ensure it is as efficient a process as possible.

Why do you think it has taken you two to come along, for there to be major innovation using this psychedelic?

G: There was lots of major innovation with psilocybin before we came along. We are looking at a substance initially developed in 1958, before being made illegal in the 1960s. There was a great deal of promise in the early research and scientific studies. And this started again in the ‘00s. What COMPASS is doing now is looking at the path to patients, and building on the work that has been done, to see how we can safely and effectively develop and use psilocybin therapy.

How you have gone about funding?

G: We were fortunate enough to fund COMPASS ourselves initially. Then we had our seed financing round with three investors to help us to build the case, do the research and manufacture the medicine. We got £25m Series A for this large clinical trial, which is a combination from the seed round, high net worth individuals, and an excellent biotech venture fund from Italy called Principia. People are just very excited by our mission and transforming the patient experience in mental health.

Why did you choose London?

G: The reason I came here years ago was to work on a project with GSK to rethink how we get medicines to the right patients at an affordable price. I couldn’t imagine doing something like that in the US, with such a different health system. I firmly believe that healthcare is a right, rather than a privilege. To be able to develop these approaches in a system that has that as a fundamental value was important to us.

K: It’s partly historic, and partly because of the value it provides. There are many excellent institutions doing innovative work in mental health, in London. All the therapists working in our clinical trial spend time assisting on the Healthy Volunteers Study we are running at the Institute of Psychiatry at King’s College London, which is looking at the effect of psilocybin on cognitive function. Therapists from across Europe, the US and Canada come for up to a week to support the sessions and work with leading international psychedelic psychotherapists. Despite Brexit, these relationships are still strong.

Find out more at https://compasspathways.com