UK scientists at Transpharmation and Clerkenwell Health combine lab and human trials, as psilocybin offers hope for people with an end-of-life diagnosis
UK scientists are aligning human and lab experiments in researching the potential of magic mushrooms to boost the effects of talking therapies to ease depression in people who are dealing with end-of-life diagnoses.
The pre-clinical laboratory studies will be carried out by the team at Kent-headquartered contract research organisation (CRO) Transpharmation, in partnership with human clinical trials led by London-based specialist psychedelic clinical research organisation Clerkenwell Health.
They are looking at how the compound psilocybin, found in magic mushrooms and already shown to ease depressive symptoms, could form part of an end-of-life healthcare plan for people who are struggling emotionally with being told they are dying.
In order to provide a sustained and integrated programme across both pre-clinical and clinical research, the combined scientific team will work together on the design and implementation of the study, working from the same baseline so that observations in one sub-team can be quickly correlated or confirmed in the other.
The approach is designed to remove the disparity between lab and clinical trials, enabling researchers and drug developers to reach stronger conclusions and, ultimately, to get drugs to market more quickly.
Transpharmation’s Scientific Liaison Dr John Huxter said: “We have an opportunity here to align methodology across the clinical and preclinical work. There have been some high-profile clinical trial failures in recent years, using treatments that nevertheless showed promise pre-clinically. In many cases, this is not because one result was right and the other wrong, but because the studies were not run in comparable ways. Working in a joined-up fashion allows you to head off those problems in advance. For example, we can agree on desired tissue exposure, dosing regimen, the route of administration, and the kind of endpoints that we use. Then we have a much better chance of translating pre-clinical study success into positive outcomes for patients.”
Clerkenwell Health CSO Henry Fisher said: “This partnership offers up a rare opportunity to deliver some truly joined up thinking in terms of pre-clinical and clinical research. Given the potential that psilocybin and related psychedelic compounds present as clinical tools across a range of indications, this is a hugely exciting development for advancing the clinical development process. This partnership will greatly assist companies in this space with accelerating their goal of market approval."
The effect of an end-of-life diagnosis can be extremely distressing for people, with severe impacts on their mental health and wellbeing, also leading to impacts on health and social care services.
Research shows that between 25% and 77% of terminally ill patients have major depression and that 40% of cancer patients develop significant distress on diagnosis, including serious worry, panic attacks, depression and post-traumatic stress disorder.
However, a double-blind trial of psilocybin use in cancer patients by researchers in the US shows optimism, with positive outcomes in mood, attitudes and behaviours which persist even months after a single dose administered in a controlled medical setting. The study notes that the temporary hallucinogenic experience within the medical setting is offset by the longer-term benefits to the patient in terms of improved mood
The European Palliative Care Research Collaborative in its guidelines for the management of depression in palliative care discusses the benefits of psychological and talking therapies and antidepressants, also noting the side effects of the latter.
The Transpharmation and Clerkenwell study will further examine the use of psilocybin combined with talking therapies.
Patients who have received end-of-life diagnoses will be treated with a course of psilocybin-assisted therapy. The therapy is posited to reduce end of life anxiety through fostering increased acceptance of their condition, and a sense of interconnectedness to the world around them, while it is hoped that psilocybin will enhance the changes in perspective that are directed by the talking therapy.
The study is led by Clerkenwell Health, the first European commercial clinical research organisation specialised in offering support for research with psychedelic compounds. The preclinical research agreement between Clerkenwell and Transpharmation highlights the UK’s position in advancing psychedelic medicine by accelerating clinical psychedelic research.
The Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) has confirmed that the UK has the capability to be a world leader in clinical trials. The UK’s current position in the psychedelic space is promising and aligns with the government’s UK Life Sciences Vision of developing tools to address mental health conditions.
Having a deep heritage in the psychedelic field, both companies bring a wealth of expertise to the table. Transpharmation previously conducted preclinical trials on ketamine and psilocybin as well as working with Compass Pathways, whereas Clerkenwell has worked with a number of psychedelic drug developers from Canada and Europe and is backed by world-leading clinical researchers in the psychedelic field.
The partnership further solidifies the UK as a research hub where life sciences companies provide services to drug developers and aligns with the government’s strategy in accelerating the delivery of innovation to patients.
Links to further information or reference reading
- The medical literature suggests that the incidence of major depression in terminally ill patients ranges from 25% to 77%.
- Best estimates are that between 15% and 50% of cancer patients experience depressive symptoms, and 5% to 20% will meet various diagnostic criteria for major depressive disorder.
- However up to 80% of the psychological and psychiatric morbidity which develops in cancer patients goes unrecognised and untreated.
- After diagnosis, 40 percent of cancer patients report developing significant distress that can include serious worry, panic attacks, depression, and PTSD, or posttraumatic stress disorder.
- Up to 40% of cancer patients develop depression, demoralisation and anxiety, which are associated with lower survival rates, higher rates of suicide, and an increased desired for hastened death.
- A recently completed phase 2 trial found that psilocybin had equal antidepressant effects to the leading prescription antidepressant, at far fewer doses and with a few side effects.
- The British public very strongly supported changes to the law to allow terminally ill patients to access psilocybin-assisted therapy. 58% of people are in favour of such a change, including majorities in every age bracket,
- One of the healthcare missions of the UK Government’s Life Sciences Vision 2021-2031 is: “Increasing the understanding of mental health conditions, including work to redefine
diseases and develop translational tools to address them.”
- Mental health care also offers the possibility of combining a set of tools, including psychological therapies and digital tools, alongside pharmacology, to improve patient outcomes and experience. The UK has an unprecedented opportunity to accelerate patient access to these evidence-based therapies and technologies through close collaboration among the MHRA, NICE, NHS and organisations performing late-stage clinical trials.
- There are 57 clinical trials recorded for psilocybin worldwide, taking place in the US and Europe only. Of these, 28 are actively recruiting for participants, of which 9 are recruiting for depression.
- Care and treatment for palliative care - KCL and European Palliative Care Research Collaborative
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer
- Pre-clinical work is often criticised for its lack of clinical validity, and important translational aspects including the nature of lab models, dosing, add-on therapies and the full-dose relationship are neglected. Addressing these would be more conducive to success in developing new drugs.