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The upcoming Phase 1B study plans to enrol up to 12 patients suffering from SUNHA, a disease belonging to a group of headache disorders called the Trigeminal Autonomic Cephalalgias (TACs), considered one of the most painful disorders known to mankind and estimated to affect approximately 46,000 patients in the US, Canada and the G5 from Europe. There are currently no approved treatments for SUNHA, which is characterized by short-lasting headaches that range from severe to excruciating and may occur over 100 times a day.

This landmark clinical trial, the first researching the effect of psilocybin on SUNHA patients, will evaluate the potential therapeutic benefits of the psychedelic compound in treating this disabling condition. ������Ƶ is also evaluating the use of wearables for data capture in this clinical trial.

Dr Fiona Dunbar, Chief Medical Advisor, ������Ƶ, says:

“SUNHA is a crippling condition for which there is very limited research and no currently approved medications. 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.”

Approval of ������Ƶ’s psilocybin clinical trial is the latest achievement in its mission to develop a fully licensed psychedelic medicine pipeline, following the company’s successful private fund raising of £14m in December 2020. The company is also developing synthetic 5-MeO-DMT, a unique psychedelic agent with a short duration of action, in the treatment of neuropsychiatric diseases, expected to enter the clinic in 2021.