Clinical Trial Evaluating Low-Dose Psilocybin.
Diamond Therapeutics Inc., a drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the dosing of the first cohort of its Phase 1 clinical trial. The trial is evaluating the safety and tolerability of low dose, non-hallucinogenic psilocybin in healthy volunteers.
“This trial will allow us to identify a safe and non-hallucinogenic dose of psilocybin. The results will help inform future clinical trials to evaluate psilocybin’s potential for treating mental health disorders,” says Dr. Edward Sellers, Professor Emeritus, Pharmacology and Toxicology, Medicine and Psychiatry at the University of Toronto and Chair of the Scientific Advisory Board for Diamond Therapeutics. “We plan to thoroughly evaluate the potential of low-dose psilocybin through a rigorous clinical trial program and believe that this is just the beginning,” adds Dr. Sellers.
The randomized, double-blind Phase 1 trial is the first systematic, placebo-controlled, single ascending dose pharmacokinetic/pharmacodynamic study of very low doses of psilocybin in humans. It is designed to assess safety and tolerability. The trial is being conducted in Toronto under the supervision of principal investigator Dr. Isabella Szeto of BioPharma Services Inc., the contract research organization working with Diamond. It will assess up to 80 subjects with escalating doses of psilocybin.
Diamond Therapeutics’ non-human research study published in the journal Frontiers in Pharmacology earlier this year demonstrated that very low, non-hallucinogenic doses and concentrations of psilocybin and its metabolite psilocin can enhance motivation and attention. Diamond believes this indicates a potential for therapeutic use in treating psychiatric disorders, including anxiety and depression. The study was the first to rigorously evaluate low doses of psilocybin and show that hallucinogenic effects are not needed for potential therapeutic benefits.
In the U.S., one in five adults experiences mental illness each year. The economic cost is also high, approximately $225 billion in 2019. Novel therapeutic options are needed to help alleviate these burdens and address unmet needs in the treatment of mental health disorders.
“We are pleased to have begun assessments of low doses of psilocybin in human trials and are optimistic the results from this study will provide the data necessary to advance rapidly to later-stage studies,” says Dr. Michael McDonnell, Chief Medical Officer of Diamond.
“This is a significant milestone for Diamond and, potentially, for the future of mental health treatment,” adds Judy Blumstock, CEO of Diamond. “We have a strong clinical research team who are focused on unlocking the full potential of low dose psilocybin in treating psychiatric disorders, and in a way that is affordable and accessible to patients.”