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.