Clairvoyant Expects to Bring Psilocybin Treatment to Market By 2025

Company reports 'compelling efficacy and safety data on psilocybin treatment' for alcohol use disorder

Clairvoyant Therapeutics Inc. says it’s on target to commercialize its psilocybin treatment for alcohol-use disorder in Canada by 2025 and the EU in 2026.

The Vancouver, B.C., company made the announcement in a news release on April 3.

The company has “compelling efficacy and safety data on psilocybin treatment” for alcohol-use disorder from a phase 2a study previously published in JAMA Psychiatry, said Clairvoyant CEO Damian Kettlewell.

“We are quickly approaching a critical and exciting moment for psilocybin and its potential use as a recognized treatment,” he said.

Clairvoyant administered its CLA-PSY-201 synthetic psilocybin formulation to 90% of the expected 128 subjects for its 24-week Phase 2b clinical trial. Participants received two dosing sessions of a 25-milligram oral capsule over eight weeks at 12 clinical sites in Canada and Europe.

A top-line read out from the clinical trial is expected in the third quarter of 2024 and a Series A financing round is currently underway, the company said.

Conditional marketing authorization of psilocybin would be based on recognition of alcohol use disorder as a serious, life-threatening or severely debilitating disease for which psilocybin demonstrates a significant increase in efficacy over existing pharmaceutical treatments.

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 confirmatory trial in H2 2025, with a read out in 2027, to support full approval of psilocybin treatment in Canada, the EU and UK.