The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Psyence Group’s Phase IIa clinical trial of psilocybin-assisted psychotherapy to treat adjustment disorder, following a diagnosis of incurable cancer.
The trial will evaluate the safety and efficacy of psilocybin-assisted psychotherapy, compared to psychotherapy alone, to treat adjustment disorders.
To be carried out at two centres in the UK, the trial is anticipated to begin by enrolling the first subject by the end of this year.
It will be conducted for a period of nearly 18 months when the trial’s primary endpoint becomes available.
For designing and delivering the trial, the company collaborated with Clerkenwell Health, a psychedelic contract research organisation (CRO).
Psyence CEO Dr Neil Maresky said: “The UK’s MHRA’s approval to conduct this clinical trial in the field of palliative care has the real potential to allow Psyence to create a paradigm shift in the treatment of patients with an incurable illness, in order to improve quality of end-of-life and the standard of care.
“Developing therapies, such as psilocybin, that reduce patients’ stress and anxiety, resulting in better quality of life for their remaining time, can be very impactful.
“The current management of adjustment disorder in palliative care has a low rate of success, indicating a big unmet medical need.”
The life science biotechnology firm works with natural psilocybin products to heal psychological trauma as well as its mental health impacts with regard to palliative care.
A serious condition, adjustment disorder impacts 40% of people with a terminal diagnosis.