Europe’s first commercial psychedelic drug testing facility opens in London, with the aim of making the UK a global leader in psychedelic research and innovation.
British start-up Clerkenwell Health aims to start trials in August at its central London facility, initially focusing on using psilocybin to help people cope with the anxiety associated with a diagnosis of terminal illness, and to support them during their end-of-life care.
The news comes as scientists and policymakers gather in London this Wednesday for the Agenda for Psych Symposium, a one-day program to discuss the latest research and the future of the psychedelics industry in Europe.
Tom McDonald, the CEO of Clerkenwell Health, said: “Psychedelic assisted therapy could be a breakthrough in mental health treatment, and the UK is well positioned to lead the way as a global leader in clinical trials after Brexit.
“Our aim is to establish the UK as the heart of the commercial psychedelic research ecosystem, working closely with mental health experts and drug developers around the world to address some of the most complex mental illnesses.”
Drug developers are increasingly exploring psychedelic compounds as potential treatments for mental illnesses such as mood disorders, PTSD and addictions, but their status as controlled substances can make it bureaucratically challenging and expensive to put them through clinical trials.
Conducting these studies in countries such as the UK – where similar studies have already been approved and regulators are more familiar with the safety profiles and potential benefits of these drugs – is one solution. However, foreign companies may need to be guided through the UK regulatory processes to avoid unnecessary delays.
This is where specialized clinical research organizations come in handy: Rather than developing one compound or class of compounds for a single condition, Clerkenwell Health will partner with multiple drug developers to address a range of complex mental illnesses using different psychedelic agents. . Training will also be given to therapists who want to work with psychedelic drugs.
Peter Rands, the CEO of Small Pharma, which is testing the use of dimethyltryptamine (DMT) for the treatment of depression, said: “There is a set of very specific conditions that must be met to use psychedelic therapy; it is quite a specialized field. The eight or so companies in clinical trials of psychedelic-based drugs rely heavily on contract research organizations to do this kind of research — especially now that they’re starting out. [late-stage] clinical trials.”
Prof David Nutt, Director of the Neuropsychopharmacology Department at Imperial College London and former Chair of the UK Drug Abuse Advisory Committee, said: “There is a clear need for clinical trials of psychedelic drugs beyond the few academic centers currently conducting this research. I therefore welcome an outside organization developing the necessary skills and expertise to support companies that want to invest in these treatments.”
The facility will be located near Harley Street and will initially employ 13 people. The first trials, planned in collaboration with Toronto-based biotechnology company Psyence, will focus on using psilocybin to treat adjustment disorder — an emotional or behavioral response to a stressful event in a person’s life. † in people with a terminal diagnosis.
Clerkenwell Health also partners with Canada- and US-based companies Mindset Pharma and Mydecine, which focus on treatments for neurological and psychiatric disorders, and psychedelic-assisted psychotherapy for depression and nicotine addiction.
Jessica Riggleman, senior director of clinical and regulatory affairs at Mydecine, said the UK is an attractive place to conduct psychedelic drug trials because of a recently introduced pathway, the Innovative Licensing and Access Pathway, which aims to increase time-to-market for innovative therapies.