Europe's first commercial psychedelic drug testing facility opens in London with the aim of making the UK a global leader in psychedelic research.
British start-up Clerkenwell Health aims to start trials at its London facility in August. Initially, the company wants to use psilocybin to help terminally ill people deal with anxiety.
Leader in psychedelic research
Tom McDonald, the CEO of Clerkenwell Health, said: “Psychedelic-assisted therapy could break new ground in mental health treatment, and the UK is well positioned to lead the way as a world leader in post-Brexit clinical trials.
“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.”
Research and regulation
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.
Psychedelics for mental illness
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) to treat depression, said: “A set of very specific conditions must be met in order to use psychedelic therapy; it is quite a specialized field. The eight or so companies conducting clinical trials with psychedelics-based medicines, rely heavily on contract research organizations to do this type of research, especially when they embark on later-stage clinical trials.”
Prof David Nutt, director of the neuropsychopharmacology division 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. That is why I welcome a third-party organization that develops 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 terminal diagnoses.
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.
Source: theguardian.com (EN)