The first patient has received a dose of psilocybin in the world’s first trial investigating psilocybin as a treatment for a rare and debilitating headache disorder – SUNHA.
Initiated by Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, the trial aims to explore the potential therapeutic benefits of low-dose psilocybin for treating Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).
The disorder is estimated to affect 40,000 patients in the US and Europe, and is typically diagnosed between the ages of 35 and 65. The condition 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.
World’s first SUNHA trial
The phase 1b clinical trial, which has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA), is being conducted as part of Beckley Psytech’s ongoing 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.
CEO of Beckley Psytech, Cosmo Feilding Mellen, commented: “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 $80m funding round and MHRA approval for the upcoming 5-MeO-DMT phase 1 clinical trial, we are delighted to achieve this additional milestone.”
The study is a multi-dose, dose-escalation trial in patients suffering from five or more attacks over the last two weeks, to evaluate proof-of-concept efficacy by analysing the impact on frequency, duration and severity of headaches.
Enrolling up to 12 patients, the trial will assess the proof-of-concept efficacy of psilocybin and determine the maximum tolerated dose 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.
“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,” said Dr Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery.
“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.”
The outcome of the phase 1b study, with proof-of-concept efficacy data, is expected in early 2022.
