Psilocybin Clinical Trial Sponsored by Clairvoyant Therapeutics Reaches 90% Randomization
Clairvoyant on target for potential commercialization of psilocybin treatment in 2025
Clairvoyant's randomized controlled trial, CLA-PSY-201, has dosed more than 90 per cent of the expected 128 subjects for its 24-week Phase 2b clinical trial of synthetic psilocybin treatment for AUD (two dosing sessions of a 25 mg oral capsule over 8 weeks) at 12 active clinical sites in
"We are quickly approaching a critical and exciting moment for psilocybin and its potential use as a recognized treatment," said
Conditional marketing authorization of psilocybin would be based on recognition of AUD as a serious, life-threatening or severely debilitating disease for which psilocybin demonstrates a significant increase in efficacy in relation to existing AUD drugs. Conditional authorization of a new medicine, known as NOC/c in
About Patient Safety
Clairvoyant is committed to ensuring the safety and well-being of participants. Participants are supported by two therapists in preparation for, and during, the psychedelic experience induced by psilocybin. Clairvoyant has trained over 50 therapists in its 35-hour training program. Therapists are monitored for adherence to the trial protocol and ethics under Clairvoyant's industry leading therapist adherence monitoring program. No ethical concerns have been identified to date.
About Alcohol Use Disorder
Alcohol is the leading risk factor for overall burden of disease among men and a significant risk factor among women.[ii] A regional study recently reported that fewer than 5 per cent of patients diagnosed with moderate to severe alcohol use disorder receive recommended medications.[iii]
About Clairvoyant Therapeutics
Clairvoyant Therapeutics is a Canadian biotechnology company trailblazing a path to global mental health through psilocybin treatment. Clairvoyant's speed-to-market clinical strategy is designed to enable psilocybin treatment in
The company's exceptional team, with deep clinical development experience, has made Clairvoyant the most advanced company developing psilocybin for the treatment of AUD. Clairvoyant is a member of Life Sciences BC.
Additional information about Clairvoyant's clinical trial may be found at ClinicalTrials.gov
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For more information:
damian@clairvoyantrx.com
[i] Bogenschutz, MP et al. (2022) JAMA Psychiatry. 2022;79(10):953-962. doi:10.1001/jamapsychiatry.2022.2096
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SOURCE: Clairvoyant Therapeutics
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