Data from Diamond Therapeutics’ trial is the first to identify a safe, active and non-psychedelic dosage of psilocybin, which the company says could open the possibility that future psilocybin-based medicines may be prescribed on an outpatient basis.
Drug development company Diamond Therapeutics has completed a Phase I clinical study of low-dose psilocybin. The study is the first randomised, double-blind, and placebo-controlled single ascending dose study to investigate low doses of psilocybin in human subjects.
As well as establishing a safe, low dose, the trial findings also demonstrate that low doses of psilocybin are psychoactive.
The trial
Fifty-six subjects were enrolled in seven separate cohorts over four and a half months for the trial, and a panel of five physicians reviewed all safety data as it became available.
Chief Medical Officer of Diamond, Dr Michael B. McDonnell, stated: ”The Diamond study assessed psilocybin’s safety and tolerability with the aim of identifying a safe, well-tolerated, active, non-psychedelic dosage of psilocybin.
“Before this study, little, if any, controlled research had been done to investigate low doses of psilocybin.
“The study showed that low-dose psilocybin is well-tolerated with no adverse events that would preclude its usage on an outpatient basis at home, removing the barrier of lengthy time spent in a clinic.”
Diamond’s founder and CEO, Judy Blumstock, added: “The results from this landmark trial exceeded our expectations bringing us closer to achieving our goal of providing new, better and more broadly accessible therapeutics to the millions of people struggling with mental health disorders.
“Based on these results, we are proceeding full tilt with our Phase II trial plans and anticipate sharing more news in the coming weeks.”
With the data generated from the Phase I study, Diamond is preparing to launch a Phase II trial investigating low-dose psilocybin’s efficacy in treating generalised anxiety disorder (GAD) – a condition that affected an estimated 2.7% of U.S. adults in the past year, and an estimated 5.7% will experience GAD at some time in their lives.
The Phase II study will be conducted in Canada under Health Canada regulations.
