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CLAIRVOYANT THERAPEUTICS Clairvoyant Surpasses 50 Per Cent Randomization in its Phase 2b Psilocybin Therapy Trial for Alcohol Use Disorder

Transparency directive : regulatory news

29/11/2023 13:00

VANCOUVER, BC / ACCESSWIRE / November 29, 2023 / Clairvoyant Therapeutics Inc. (www.clairvoyantrx.com), the clinical-stage pharmaceutical company developing psilocybin therapy for alcohol use disorder (AUD), today announced that it has randomized more than 50 per cent of the expected 128 subjects for its 24-week Phase 2b clinical trial of synthetic psilocybin (25mg oral capsule). The double-blind, randomized controlled trial was initiated in October 2022 and is designed to assess multiple efficacy and safety endpoints.

"We are pleased that the pace of subject enrollment is at the upper end of our expectations. We are on track for an interim data read out in February 2024 and a top line read out in Q2 2024," stated Damian Kettlewell, CEO, Clairvoyant.

"Our goal is to be the first company in the world to obtain regulatory approval for the clinical use of psilocybin in AUD. The medical benefits of psychedelic compounds like psilocybin have been supressed for decades. We are pleased that regulatory authorities are now engaged in evidence-based approaches to review these potentially remarkable compounds."

Clairvoyant has been motivated to explore psilocybin therapy for AUD as a result of pioneering academic work by researchers in the U.S. Positive clinical results will support Clairvoyant's goal to help millions of AUD patients around the world.

Alcohol is the leading risk factor for overall burden of disease among men and a significant risk factor among women (source: WHO Global Status Report on Alcohol and Health 2014). A regional study recently reported that fewer than 5 per cent of patients diagnosed with moderate to severe alcohol use disorder receive recommended medications (source: BC Centre for Substance Use, 2023).

About Clairvoyant Therapeutics

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 deep clinical development experience, has made Clairvoyant the most advanced company developing psilocybin therapy 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
damian@clairvoyantrx.com

SOURCE: Clairvoyant Therapeutics



View source version on accesswire.com:
https://www.accesswire.com/810748/clairvoyant-surpasses-50-per-cent-randomization-in-its-phase-2b-psilocybin-therapy-trial-for-alcohol-use-disorder

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