Psilocybin Clinical Trial Sponsored by Clairvoyant Therapeutics Reaches 90% Randomization

Clairvoyant on target for potential commercialization of psilocybin treatment in 2025

VANCOUVER, BC / ACCESSWIRE / April 3, 2024 / Clairvoyant Therapeutics Inc. (www.clairvoyantrx.com), the private clinical-stage pharmaceutical company developing psilocybin treatment for alcohol use disorder (AUD), today announced that it is on target to potentially become the first in the world to commercialize clinically validated psilocybin treatment. Clairvoyant believes it may achieve this milestone in H2 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 Canada and Europe. A top line read out from the clinical trial is expected in Q3 2024 and a Series A financing round is currently underway.

"We are quickly approaching a critical and exciting moment for psilocybin and its potential use as a recognized treatment," said Damian Kettlewell, CEO, Clairvoyant. "We have the compelling efficacy and safety data on psilocybin treatment for AUD from a phase 2a study previously published in JAMA Psychiatry^[i] in 2022 and earlier data published in 2015. Assuming our trial has similar results, we believe there is a regulatory pathway to conditional market authorization in Canada in 2025 and in the EU in 2026."

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 Canada and CMA in Europe, allows the marketing of a new drug with the condition that the sponsor undertake additional studies to verify the clinical benefit. Under NOC/c and CMA, companies are required to conduct confirmatory studies to validate the initial efficacy evidence. Clairvoyant intends to launch a pivotal confirmatory trial in H2 2025, with a read out in 2027, to support full approval of psilocybin treatment in Canada, the EU and UK.

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 Canada, EU & the UK for patients living with Alcohol Use Disorder (AUD) beginning in 2025.

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 Kettlewell
[email protected]