Clerkenwell Health have signed their first multi-million pound contract to design and run multi-phase trials with Psyence Group.
- Psyence Group is a Canadian-listed life science biotechnology company
- Clerkenwell is a specialist psychedelic Contract Research Organisation (CRO) based in the United Kingdom
- The first studies will examine the effectiveness of psilocybin-assisted therapy to help patients come to terms with end-of-life diagnoses
- The deal further positions the United Kingdom as an attractive destination for international psychedelic drug developers looking to conduct trials
Psyence Group is a Canadian-listed life science biotechnology company pioneering the use of natural psilocybin to heal psychological trauma and its mental health consequences in the context of palliative care.
The UK is becoming a global leader in psychedelic research, and the need to support drug developers in the market is growing. Clerkenwell is committed to helping psychedelic drug development companies, the first of which is the Psyence Group.
Clerkenwell will provide advisory and operational support to Psyence Group for the design and delivery of the trial which will be conducted in the United Kingdom and aligned with European, Canadian and US clinical trial guidelines.
Commenting on the collaboration, Dr Neil Maresky, the CEO of Psyence Group said “We are delighted to partner with Clerkenwell as we prepare to commence our first palliative care focused clinical trial. Clerkenwell’s expertise, depth of knowledge and progressive thinking made them the ideal partner to collaborate with”.
Tom McDonald, the Clerkenwell CEO stated, “Having designed our own trial examining different doses of psilocybin and digitally-supported therapy for the treatment of depression, we are delighted to draw on our experience and provide advisory and operational support to Psyence. We will help them establish the procedures and protocols required to successfully run a clinical trial in order to gain regulatory approval for their products”.
The clinical trials will be jointly designed with Dr. Dingle Spence, a Palliative Care Specialist and Psyence’s principal medical advisor. “There is an historic opportunity for psychedelics such as psilocybin to play a significant role in Palliative Care.” says Dr. Spence.
The preclinical studies will be conducted later this year before moving into human trials in 2022. 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.
Unlike a number of studies researching synthetic compounds, the trial will use natural compounds produced at Psyence’s federally licensed facility in Lesotho in Southern Africa. Designed and constructed to The British Standards Institute (BSI) and Good Manufacturing Practice (GMP) standards, their facility produces certified, high-quality psilocybin yielding mushrooms for research and development purposes.
Commenting on the trial, Clerkenwell’s CSO Dr Henry Fisher said “Psilocybin has shown great promise in aiding the mental health and well-being of people in palliative care and with terminal diagnoses in previous small scale studies. It is exciting for us to be able to work with Psyence on building a greater base of evidence for treating this population, so that the mental health care they receive can be built into a holistic treatment plan, and their quality of life is maintained.”
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About Clerkenwell Health
Clerkenwell Health is an innovative, UK-based mental health start-up building a platform to accelerate patients’ access to a range of psychedelic-assisted therapies over the coming years. Clerkenwell is focused on helping its clients generate the clinical data required to mainstream these exciting treatment methodologies with doctors and regulators alike.
The team is led by CEO Tom McDonald, a former Accenture pharmaceutical specialist with a focus on patient-centric care and CSO Dr Henry Fisher, a chemist and drug policy expert. Patient therapy is led by Dr Sara Tai, a clinical psychologist, a Senior Lecturer in Clinical Psychology at the University of Manchester and an expert in psychotherapy in clinical trials of psychedelic medicine. www.clerkenwellhealth.com
About Psyence Group
Psyence, a public life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), sets the global standard for natural psychedelics. Psyence leads the way in natural psilocybin and other psychedelics for the healing of psychological trauma and its mental health consequences in the context of palliative care. The name “Psyence” combines the words psychedelic and science to affirm the team’s commitment to producing psychedelic medicines developed through evidence-based research.
Informed by nature and guided by science, Psyence built and operates one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities. The team brings international experience in both business and science and includes experts in mycology, neurology, and drug development. Psyence works to develop advanced psilocybin products and other psychedelic breakthroughs for research institutes, clinics, therapeutic immersions, and destination experiences for clinical research. The team is also developing a nutraceutical mental wellness collection that supports improved focus, calm, and sleep.
Psyence’s four key divisions (Psyence Production, Psyence Therapeutics, Psyence Function, and Psyence Experience) anchor an international footprint with operations in Canada, United States, United Kingdom, Jamaica, Brazil, South Africa, and Australia. www.psyence.com