Europe’s first psychedelic drug trial firm to open in London

The goal of opening Europe's first commercial facility for drug trials is to make the UK a global leader in research and innovation.

In August, Clerkenwell Health will begin trials in London to help people deal with the anxiety associated with a diagnosis of terminal illness and to support them through their end-of-life care.

The news comes as scientists and policymakers gather in London this Wednesday for the Agenda for Psych Symposium, a daylong programme to discuss the latest research and the future of the psychedelics industry in Europe.

Tom McDonald, the CEO at Clerkenwell Health, said that the UK is well placed to be at the forefront of clinical trials after leaving the EU.

The aim is to establish the UK as the heart of the commercial psychedelic research community, working closely with mental health experts and drug developers around the world to tackle some of the most complex mental health conditions.

Drug developers are increasingly looking at the potential of compounds such as idiosyncrasy as treatments for mental health conditions such as mood disorders, but their status as controlled substances can make it difficult to progress them through clinical trials.

One solution is to conduct these studies in countries where similar trials have already been approved and regulators are more familiar with the safety profiles and potential benefits of these drugs. Foreign companies may need to shepherd the regulatory processes in the UK.

Clerkenwell Health will work with multiple drug developers to tackle a range of complex mental health conditions using various psychedelic agents, rather than developing one compound or class of compounds for a single condition. It will offer training for therapists who want to work with drugs.

A set of very specific conditions need to be met to do psychedelic-assisted therapy. As they begin to enter late-stage clinical trials, the eight or so companies in clinical trials with psychedelic-based medicines rely on contract research organizations to do this kind of research.

Prof David Nutt is the director of the neuroscience unit at Imperial College London and the former chair of the UK's advisory committee on the misuse of drugs. I welcome an external organisation that can help companies invest in these treatments.

13 members of staff will be the first to work at the facility. The first trials will focus on the treatment of adjustment disorder, which is an emotional or behavioural reaction to a stress event.

The companies that Clerkenwell Health is working with are Mindset Pharma and Mydecine, which focus on treatments for neurological and psychiatric disorders.

The UK is an attractive place to conduct drug trials because of the Innovative Licensing and Access Pathway, which aims to reduce the time to market for innovative therapies, according to Jessica Riggleman, senior director of clinical and regulatory affairs at Mydecine.