Clairvoyant Therapeutics, a clinical stage biotech company focused on the development of psychedelic drug therapies for the treatment of addiction, is pleased to announce the first patient has been dosed in the company’s Phase 2 clinical trial investigating psilocybin for the treatment of alcohol use disorder (AUD).
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). Psilocybin is the pharmaceutical agent in certain mushrooms which is known to induce a temporary psychedelic state.
“Having our first patient dosed is a key milestone that we have been working towards for more than two years. We look forward to initiating additional trial sites at leading universities and private clinical sites in Canada and Europe. With each step, we come closer to fulfilling our mission to develop psilocybin therapy for patients with AUD.”Damian Kettlewell, CEO, Clairvoyant.
“We are pleased to be part of the ongoing investigation of psilocybin as a therapeutic agent,” said Dr. Eugene Okorie, MD, FRCPC, the clinical trial investigator at Okanagan Clinical Trials where the first CLA-PSY-201 patient is being treated. “We look forward to helping advance the medical community’s understanding of, and thinking related to, the potential benefit of psilocybin for patients.”
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. In addition to the treatment of the first patient in Canada, Clairvoyant has also received regulatory approval and has initiated the first two clinical sites in Finland. The company plans to register psilocybin therapy for AUD in 2026 in two continents.
Dustin Robinson, Managing Principal of Iter Investments, which led Clairvoyant’s seed round with investors Negev Capital, Ambria Capital and others, commented on the strengths of the company’s approach stating, “As an early-stage investor, every deal we invest in has a certain amount of execution risk. Clairvoyant’s dosing of its first patient is another example of Clairvoyant mitigating this execution risk through its detailed strategic plan, focused business strategy, and stellar teamwork. We look forward to continuing to work alongside Clairvoyant as we continue to execute on its plan.”
CLA-PSY-201 is a clinical trial that compares 25mg synthetic pharmaceutical grade oral psilocybin capsules to placebo in the context of Motivational Enhancement Therapy (MET). The clinical trial is initiating at 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. Globally, mortality from alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS, and diabetes.
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 2 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).