First patient dosed with psilocybin in study exploring how the hallucinogenic treats headaches

The first patient has been dosed with psilocybin in a world-first clinical trial exploring how the hallucinogenic medicine can treat Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).

The phase 1b study is being conducted by Beckley Psytech in collaboration with the Psychedelic Trials Group, led by Dr. James Rucker at King’s College London; Dr. Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery; and Dr. Giorgio Lambru, Consultant Neurologist at Guy's & St Thomas' NHS Foundation Trust.

The outcome of the study and proof-of-concept efficacy data is expected to be available in early 2022.

The phase 1b trial has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA) and will evaluate the potential therapeutic benefits of low-dose as a treatment for SUNHA. SUNHA is characterised by short-lasting, painful headaches that can occur over 100 times a day and there is currently no approved treatment for the condition. SUNHA is typically diagnosed between the ages of 35 and 65.

Up to 12 patients are being recruited for the study which seeks to evaluate proof of concept efficacy of psilocybin on patients suffering from SUNHA attacks in over five days a week. The study will look to determine the maximum tolerated dose (MTD) or recommended dose for further development. On day one patients will receive dose one, on day six dose two, on day 11 dose three, with a follow up visit on day 25.

Psilocybin is the key ingredient found in hallucinogenic mushrooms. In the life science industry, it is currently being explored as a means to treat varying types of mental health disorders and neurological conditions such as SUNHA.

Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “We are very excited to initiate this world-first clinical trial with Dr. Matharu and Dr. Lambru. This represents a significant milestone for Beckley Psytech and the patients for whom this product has the potential to benefit. SUNHA is a severely debilitating disease which affects thousands of patients, and for which there is no currently approved treatment. The potential medical advantages of psychedelic agents, such as psilocybin, could be transformational to the quality of life for those affected by this disease. Following on from our recent highly successful $80 million funding round and MHRA approval for the upcoming 5-MeO-DMT phase 1 clinical trial, we are delighted to achieve this additional milestone.”

Dr Manjit Matharu, consultant neurologist and clinical lead of the Headache Group at the National Hospital for Neurology and Neurosurgery, said: “I have been involved with research into SUNHA for 22 years and have seen personally the devastating effect this condition can have on so many patients. I am delighted that Beckley Psytech is developing a truly novel approach which could lead to a safe and effective product for these patients with such a high unmet medical need. I look forward to investigating its safety and efficacy in this ascending dose clinical trial.”