Magic Mushrooms Vs. Psychotherapy For Incurable Cancer Diagnosis Moves Forward In UK Clinical Trials

UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved Psyence Group Inc. PSYGF’s application to assess the efficacy and safety of psilocybin-assisted psychotherapy compared to psychotherapy alone for treating adjustment disorder following an incurable cancer diagnosis in a Phase IIa clinical study.

The MHRA is the UK’s regulatory body equivalent to North America’s Health Canada and FDA, hence the importance of this green light. 

The company’s CEO, Dr. Neil Maresky, believes it holds “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.”

The trial is expected to begin by the end of 2022 and be conducted at two UK centers in collaboration with renowned psychedelic contract research organization Clerkenwell Health.

Psyence’s work focuses on natural psychedelics, specifically producing natural psilocybin products for the healing of psychological trauma and its mental health consequences within the palliative care context.

The company has a licensed commercial psilocybin mushroom cultivation and production facility in Lesotho, Southern Africa, and throughout its three divisions -Production, Therapeutics and Function, it holds operations with international partners in Canada, the UK, the US, Australia and South Africa.

Adjustment Disorder

Approximately 40 million people require palliative care annually. Of the 14% that actually receive treatment, 75% exhibit high levels of depression, anxiety or psychosocial distress after diagnosis.

In particular, adjustment disorder makes its appearance in 40% of patients with a terminal diagnosis. This condition severely affects the patients' and their family’s well-being and may lead to over-utilization of healthcare resources and medications in their search to find coping mechanisms.

This is where the new treatment alternative comes in.

“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,” considering “the current management of adjustment disorder in palliative care has a low rate of success indicating a big unmet medical need,” Dr. Maresky stated. 

According to Clerkenwell’s CEO, Tom McDonald, PsyBio’s clinical trial is “one of very few looking at this indication.”

The study is expected to run for approximately 18 months, “when the primary endpoint will be available,” he further explained.  

Photo by Haley Lawrence on Unsplash