Diamond Therapeutics has received approval from Health Canada to carry out a clinical trial for the treatment of mental health conditions with low-dose psilocybin.
Drug development company Diamond Therapeutics has received a No Objection Letter from Health Canada which will enable it to carry out a Phase 1 randomised, placebo-controlled, double-blind human clinical trial to evaluate low doses of psilocybin for the treatment of mental health.
Unlocking the use of psilocybin
Building on the results of previous animal research conducted by Diamond that demonstrated for the first time that low, non-hallucinogenic doses of psilocybin hold potential for therapeutic use, the study will evaluate the safety and pharmacokinetics of low doses of psilocybin in an estimated 80 study participants.
Diamond says the findings could help unlock the use of low-dose psilocybin to treat psychiatric disorders such as anxiety and depression.
Chair of Diamond’s scientific advisory board, Dr Edward Sellers, said: “This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds.”
“We are grateful to Health Canada for their support of this groundbreaking study,” added Judy Blumstock, CEO of Diamond. “We’re very excited to commence our clinical programme. It brings us one step closer to creating therapeutics that can help more people access effective and safe treatments for mental health conditions.
“It’s because of the hard work of our team, partners and advisors that we’ve been able to achieve this significant milestone,” she says.
Diamond will also plans to launch a Phase 2 trial to investigate the efficacy of low-doses of psilocybin in treating anxiety, which will be conducted in both Canada and the US, and to support a study to explore its effects on patients with moderate depression.
