Beckley Psytech has dosed the first patient in a world-first clinical trial exploring the effects of psilocybin for treating Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).
The outcome of the Phase Ib study, with proof-of-concept efficacy data, is expected to be available in early 2022. The clinical trial 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.
The Phase Ib trial has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA) and will evaluate the potential therapeutic benefits of low-dose psilocybin 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.
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 I 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.”
This is a multi-dose, dose escalation Phase I trial in patients who suffered with over five attached per day over the last two weeks, to evaluate proof of concept efficacy by analysing the impact on frequency, duration and severity of headaches. The study will enrol up to 12 patients to assess the proof-of-concept efficacy of psilocybin and 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.