Clairvoyant Therapeutics, a Canadian biotech company focused on the development of psychedelic drug therapies for the treatment of addiction, is pleased to announce it has received regulatory approval from the Finnish Medicines Agency (FIMEA) to proceed with the company’s Phase 2 clinical trial investigating psilocybin, a compound found in psychedelic mushrooms, for the treatment of alcohol use disorder (AUD) in Finland.
Clairvoyant’s randomized, controlled, clinical trial, CLA-PSY-201, will evaluate the safety and efficacy of a 25 mg synthetic psilocybin capsule versus placebo, with Motivational Enhancement Therapy (MET). Based on the FIMEA approval, Clairvoyant has initiated the first of four planned trial sites in Finland. Earlier this year, Clairvoyant also announced it had received Health Canada approval to proceed with the trial in Canada and a number of potential patients have recently entered the screening process.
“We are delighted to have approval to move forward with our trial in a second country and have our first site initiated there. We’ve had strong interest from patients about participating in our Canadian sites and are excited to begin the recruitment of patients in Finland. Most importantly, we are anxious to continue adding to our global understanding of how psilocybin can help those living with AUD.”Damian Kettlewell, CEO, Clairvoyant
Support for the use of psilocybin as a therapeutic agent is growing. Recently published data showed that two doses of psilocybin reduce heavy drinking by 83 per cent on average among heavy drinkers when combined with psychotherapy.[i] These encouraging clinical results related to the use of psilocybin for the treatment of AUD help validate Clairvoyant’s own clinical approach.
Clairvoyant aims to be the first company in the world to secure market authorization for psilocybin in Europe, the UK, and Canada to benefit patients living with AUD. The company is on target to obtain approval for psilocybin therapy for AUD in the EU, UK & Canada in 2026.
CLA-PSY-201 is a clinical trial that compares 25 mg of synthetic pharmaceutical grade oral psilocybin capsule to placebo in the context of Motivational Enhancement Therapy (MET). The clinical trial is initiating approximately 15 clinical sites in Canada and Europe. Clairvoyant’s extensive therapist training program is rolling out at each clinical site in order to ensure the highest professional and ethical standards. An interim data readout is anticipated in mid-2023.
About Alcohol Use Disorder
According to the World Health Organization, 283 million people aged 15 years and older are at risk of alcohol use disorder.[ii] Globally, mortality from alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS, and diabetes.[ii]
Clairvoyant Therapeutics is a Canadian biotech company founded by an exceptional team with a proven clinical track record and deep drug development experience bringing new drugs to market. Clairvoyant is operating a multi-country multi-site Phase 2b psilocybin therapy randomized control trial for alcohol use disorder (AUD).
Clairvoyant is committed to meeting the highest standards of verified social and environmental performance, public transparency and legal accountability to balance profit and purpose and is a pending B Corporation Certification. Clairvoyant is a member of Life Science BC and Biotechnology Innovation Organization (BIO).