Oxford-headquartered Beckley Psytech has announced the first patient has been dosed in a ‘world-first’ clinical trial evaluating the effects of psilocybin for the treatment of short-lasting unilateral neuralgiform headache attacks (SUNHA).

Outcomes from the Phase Ib trial are expected to be available in 2022, with the trial being conducted as part of Beckley Psytech’s ongoing collaboration with the Psychedelic Trials Group.

The early-stage trial, which has been approved by the UK Medicine and Healthcare products Regulatory Agency (MHRA), will evaluate the potential therapeutic benefits of low-dose psilocybin as a treatment for SUNHA.

The rare headache disorder is characterised by short-lasting, painful headaches that can occur over 100 times a day – currently there is no approved treatment for the condition.

“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 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,” he added.