First Patient Dosed in Europe in Clairvoyant’s Phase 2b Clinical Trial Exploring Psilocybin Therapy as a Treatment for Alcohol Use Disorder
VANCOUVER, BC / ACCESSWIRE / March 20, 2023 / Clairvoyant Therapeutics ("Clairvoyant") is pleased to announce that the first clinical trial participant in Finland enrolled in CLA-PSY-201 has received their first dose of the drug along with Motivational Enhancement Therapy (MET). CLA-PSY-201 is the company's placebo-controlled, randomized, multi-site phase 2b trial exploring psilocybin therapy as a treatment for alcohol use disorder (AUD).
The first CLA-PSY-201 trial site in Finland is overseen by principal investigator, Dr. Hannu Alho. Dr. Alho is a Professor with the Finnish National Institute for Health and Welfare (THL) and Chief Doctor at Addiktum Oy, a Finnish company founded and owned by drug addiction treatment specialists and a research center for the study.
"My team and I have been researching addiction and AUD for decades," said Dr. Alho. "Together, we have conducted a number of trials exploring potential therapies to treat addiction. Considering the strong efficacy of a recently published psilocybin and AUD study, we are excited to proceed with the Clairvoyant study. Our goal is to contribute to the global understanding of psilocybin as a therapeutic option for AUD."
This milestone means the trial is now underway on two continents. "We are excited to randomize our first patient in Europe," said Damian Kettlewell, CEO and Co-founder, Clairvoyant. "Likewise, the Clairvoyant team is pleased that six clinical trial sites are recruiting patients in Canada and Europe. An accelerating number of dosing visits are scheduled in March and subsequent months. We look forward to opening eight additional sites in the coming quarter to expedite patient recruitment and have a clear line of sight on an interim data readout in Q3 2023 and full recruitment by Q4 2023. We appreciate the ongoing support of our experienced and well-resourced clinical, regulatory and financial team and partners."
Clairvoyant aims to be the first company to secure market authorization for psilocybin as a therapeutic product in Europe, the UK and Canada. Clairvoyant's clinicaltrials.gov listing currently lists nine clinical site partners.
"The Clairvoyant team is doing a tremendous job executing on the company's vision to help address the unmet medical needs of those living with AUD," said Dustin Robinson, Director, Clairvoyant. "I am pleased with Clairvoyant's current path and progress and believe Clairvoyant will be the first company to register psilocybin as a therapeutic product, in 2026."
Clairvoyant remains on track to publish an interim data readout later this year.
CLA-PSY-201 is a clinical trial that compares 25mg synthetic pharmaceutical grade oral psilocybin capsule to placebo in the context of Motivational Enhancement Therapy (MET). Psilocybin is a natural compound originally identified in so-called "magic mushrooms". The clinical trial is initiating at approximately 14 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.
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.[i] Globally, mortality from alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS, and diabetes.[i]
Clairvoyant Therapeutics is a Canadian biotechnology company trailblazing a path to global mental health through psilocybin therapy.
Clairvoyant's speed-to-market clinical strategy is designed to enable psilocybin therapy in the EU, UK & Canada to treat patients living with Alcohol Use Disorder (AUD) beginning in 2026.
The company's exceptional team, with a proven clinical track record and deep drug development experience, has made Clairvoyant the most advanced company globally developing psilocybin therapy for the treatment of 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. Clairvoyant is a member of Life Science BC and Biotechnology Innovation Organization (BIO).
For more information:
[i] World Health Organization. Global alcohol action plan 2022-2030 to strengthen implementation of the Global Strategy to Reduce the Harmful Use of Alcohol First draft. June 2021.
SOURCE: Clairvoyant Therapeutics
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