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UK Regulators Approve Beckley Psytech Study of Psilocybin for Debilitating Headache Condition

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UK-based Beckley Psytech has received Clinical Trial Authorisation from UK authorities, allowing it to explore the effects of psilocybin in the treatment of short-lasting unilateral neuralgiform headache attacks (SUNHA).

Short-lasting unilateral neuralgiform headache attacks (SUNHA)

SUNHA is a debilitating disease characterised by headaches that range from severe to excruciating, and may occur in excess of 100 times a day (see Levy & Matharu, 2018). They are distinct from cluster headaches, around which a flurry of research into psychedelic medicines exists, but belong to the broader group of Trigeminal Autonomic Cephalalgias (TACs) headache disorders.

Around 46,000 people suffer from SUNHA across the U.S., Canada and Western Europe. At present, “there is very limited research and no currently approved medications,” according to Beckley’s Chief Medical Advisor, Dr Fiona Dunbar.

Dunbar went on to explain, “We believe that psychedelic medicine has the potential to make a significant difference to the quality of life of patients suffering with this disease, and are very excited to receive approval for our clinical trial and to further investigate the safety profile and efficacy of psilocybin as a treatment.”

Phase 1B Study to Commence Q1

Beckley Psytech plans to enrol up to 12 patients suffering SUNHA, as part of a Phase 1B clinical trial. It will be the first to evaluate the potential therapeutic benefits of psilocybin in the treatment of this headache condition.

In accordance with a pronounced trend in the psychedelics space of late, Beckley noted that they are evaluating the use of wearables for data capture.

Given that the Medicine and Healthcare Products Regulatory Agency (MHRA) has approved the trial, Beckley expects to initiate the study this quarter: Q1 2021.

Beckley’s Research Pipeline

Beckley Psytech’s Research Pipeline structure,

Psilocybin is a ‘classical’ psychedelic, meaning this study belongs to the first ‘prong’ of Beckley’s tripartite research pipeline. The company is also set to evaluate 2nd generation psychedelics, such as 5-MeO-DMT, and 3rd generation New Chemical Entities (NCEs).

Indeed, their proposed investigation of 5-MeO-DMT was the primary basis of a £14m round, led by Noetic Fund and Bail Capital, in December 2020.