Psyence Group Inc. (CSE: PSYG | OTCQB: PSYGF), a life science biotechnology company pioneering the use of natural psychedelics in mental health and well-being, is delighted to announce that it has received approval for its Phase IIa clinical trial from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK equivalent regulatory body to Canada’s Health Canada and the US’s FDA. The clinical trial will assess the efficacy and safety of psilocybin-assisted psychotherapy versus psychotherapy alone for the treatment of adjustment disorder due to an incurable cancer diagnosis.
Psyence has partnered with a leading psychedelic Contract Research Organisation, Clerkenwell Health, to design and deliver the clinical trial. Clerkenwell has experience in conducting psychedelic research and the trial will be conducted at two centers in the United Kingdom.
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. It is a privilege to conduct research with psilocybin that may result in significant improvements in patients’ lives. We are thrilled that we can now progress this important trial.”
Dr. Neil Maresky, Psyence Chief Executive Officer
An estimated 40 million people require palliative care annually, with 75% of these patients exhibiting a high burden of depression, anxiety or psychosocial distress after diagnosis.
Adjustment disorder is a serious condition affecting 40% of patients with a terminal diagnosis. It severely affects the patient’s and their family’s quality of life and, as such, can lead to over utilisation of healthcare resources and medications.
“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,” Dr. Maresky says.
“We are very excited about being involved with this study, one of very few looking at this indication. Clerkenwell Health brings utmost rigour to the performance of clinical trials, especially needed at this stage of psilocybin research,” says Tom McDonald, Clerkenwell Health Chief Executive Officer. “The study will likely enter the first patient by the end of this year or sooner and is expected to run for approximately 18 months when the primary endpoint will be available.”
Psyence aims to commence this study by the end of the year.
ABOUT PSYENCE GROUP
Psyence is a life science biotechnology company listed on the Canadian Securities Exchange and (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), with a focus on natural psychedelics. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care.
Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.
Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Lesotho, Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development. We work to develop advanced natural psilocybin products for clinical research and development.
Our key divisions, Psyence Production, Psyence Therapeutics, and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, South Africa and Lesotho, and a presence in the United States and Australia