VANCOUVER, BC / ACCESSWIRE / January 20, 2022 / 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 Health Canada approval to initiate a Phase 2 clinical trial investigating psilocybin for the treatment of alcohol use disorder (AUD) (formerly called alcoholism).
Clairvoyant's randomized, controlled, clinical trial will evaluate the safety and efficacy of a 25 mg synthetic psilocybin capsule versus placebo, with Motivational Enhancement Therapy (MET). Regulatory submissions are also underway in the EU.
To the best of the company's knowledge, Clairvoyant is the most advanced company in the world focused on developing psilocybin for AUD.
"We are pleased and proud to have approval to take the next step in our psilocybin research," said Damian Kettlewell, CEO, Clairvoyant. "Our short track clinical strategy is gaining momentum and we look forward to the insights this next phase of investigation will produce with respect to the potential of psilocybin as an effective therapeutic agent for AUD."
Health Canada recently stated that "clinical trials remain the best mechanism to authorize the sale of restricted drugs (or any other unapproved drug) for the treatment of patients."1 Clairvoyant believes that its Phase 2 trial is another important step towards making psilocybin available to patients in Canada and potentially other countries as an approved therapeutic agent.
"At Clairvoyant, it is our hope that the results of this trial will support the company's continued development of a unique therapeutic treatment model addressing the significant unmet medical need for AUD patients," adds Kettlewell.
According to the World Health Organization, 283 million people aged 15 years and older live with alcohol use disorders.2 "We continue to believe that our commitment to exceptional science and clinical rigor will help us develop a solution for those challenged with alcohol use disorder," stated Mark Tyndall, Chief Medical Officer, Clairvoyant.
Clairvoyant's clinical investigations will be expanded to other indications as evidence accumulates. Early studies conducted in leading academic centres have shown signals that psilocybin could be a safe and effective medicine for patients with alcohol use disorder, smoking addiction, opioid addiction, depression, anxiety and other mental illnesses when administered with psychological support from specially trained therapists.
Clairvoyant Therapeutics is a Canadian biotechnology company at the forefront of a growing psychedelic therapy industry and operates under the principles of open science. Our team has a successful track record designing and operating clinical trials for therapeutic products and bringing new drugs to market.
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 Sciences BC, an industry association that represents the life science community of British Columbia at the local, national, and international level.
For more information, please visit www.clairvoyantrx.com.
For more information:
[i] Government of Canada. Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/2021-271. Canada Gazette, Part II, Volume 156, Number 1.
[ii] 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