Clairvoyant Therapeutics
3.4.2024 14:04:47 CEST | ACCESS Newswire | Press release
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.
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.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
-30-
For more information:
Damian Kettlewell
damian@clairvoyantrx.com
[i] Bogenschutz, MP et al. (2022) JAMA Psychiatry. 2022;79(10):953-962. doi:10.1001/jamapsychiatry.2022.2096
[ii] World Health Organization. Global Status Report on Alcohol and Health 2014 Accessed March 2024 at WHO Global Status Report on Alcohol and Health 2014
[iii] Maria Eugenia Socias, Frank Xavier Scheuermeyer, Zizhan Cui, Wing Yin Mok, Alexis Crabtree, Nadia Fairbairn, Seonaid Nolan, Amanda Slaunwhite, Lianping Ti. (2023) Addiction. 2023; Volume118, Issue11: 2128-2138. doi.org/10.1111/add.16273
SOURCE: Clairvoyant Therapeutics
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Karbon-X Expands European Compliance Market Capabilities With Spanish EU ETS Registry Account9.7.2026 16:00:00 CEST | Press release
Milestone Strengthens Karbon-X's European Regulatory Infrastructure and Expands Its Operational Capabilities Within the World's Largest Compliance Carbon Market CALGARY, AB / ACCESS Newswire / July 9, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company operating across global carbon markets and climate infrastructure, today announced the establishment of its European Union Emissions Trading System (EU ETS) Registry Account in Spain following regulatory approval from Spain's Office for Climate Change (Oficina Española de Cambio Climático). The milestone further strengthens the Company's regulatory infrastructure in Europe and marks another step in the continued execution of its European growth strategy. Following regulatory approval, the Company's EU ETS Registry Account has been established within the Spanish section of the Union Registry. Final technical activation by the Spanish Registry (RENADE) is expected shortly, aft
Parents Are Underestimating Their Kids' Digital Lives - Especially With AI: New Family Online Safety Institute Research9.7.2026 16:00:00 CEST | Press release
Survey of 4,000+ U.S. and Australian families finds children report doing more online - from social media to generative AI - than their parents realize. WASHINGTON, D.C. / ACCESS Newswire / July 9, 2026 / The Family Online Safety Institute (FOSI) today released Beyond Borders: U.S. and Australian Families on Online Safety, Screen Use, and the Digital Lives of Kids, the fourth wave of its bi-annual Online Safety Survey. When asked whether their child had used generative AI in the past week, 27% of parents said yes. When children were asked the same question about themselves, 38% said yes, an 11-point gap. The pattern held across nearly every online activity measured, including scrolling social media (46% of parents vs. 54% of children) and posting on social media (30% vs. 38%). Fielded in spring 2026 by Ipsos with more than 4,000 parents and children ages 10-17 across the United States and Australia, the research reveals a consistent and significant gap: children report doing more onlin
Haier Europe Appoints Stagwell (STGW) as Creative Agency for the Haier Brand, Following Ingenuity+ Pitch Process9.7.2026 09:35:00 CEST | Press release
LONDON, GB / ACCESS Newswire / July 9, 2026 / Today, Haier Europe appoints Stagwell (NASDAQ:STGW), the challenger network transforming marketing through AI, as its lead creative agency for the Haier Brand, following a competitive pitch process managed by Ingenuity+. Haier strives to deliver premium appliances powered by intelligent technology, naturally designed around customers, empowering them every day as their needs evolve. Stagwell was selected to support the Haier brand through its next phase of growth, bringing its "More Creation, More Possibilities" brand payoff to life through creative communications across Europe. Coordinated by a Client Service Team based in the Italian office, Stagwell will lead creative strategy and campaign development, helping the Haier brand in Europe to translate its vision into a consumer-relevant communication platform across markets and product lines. Stagwell's digital agency, Assembly Digital Commerce, will support with content for online and e-co
Karbon-X Announces Strategic Partnership to Evaluate Kenya BioHub Initiative8.7.2026 15:00:00 CEST | Press release
Company to conduct feasibility assessment for integrated land restoration and renewable energy initiative as part of its strategy to expand its international climate project development pipeline. CALGARY, AB / ACCESS Newswire / July 8, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company delivering end-to-end services across global carbon markets and climate infrastructure, today announced a strategic partnership with REGID International ("REGID") to jointly evaluate the Kenya BioHub Initiative, an integrated climate infrastructure program designed to restore degraded land, produce sustainable biomass, and support industrial decarbonization in Kenya. The partnership reflects Karbon-X's disciplined approach to identifying, evaluating, and selectively advancing climate infrastructure opportunities with long-term development potential as part of its strategy to expand its international project development pipeline. The Kenya B
Frame Security Launches KnowBetter as AI Reshapes Social Engineering8.7.2026 14:00:00 CEST | Press release
AI Is Rewriting the Social Engineering Playbook. Security Awareness Training Hasn't Caught Up. Organizations must KnowBetter. NEW YORK CITY, NY / ACCESS Newswire / July 8, 2026 / Security teams have spent two decades training employees to spot a familiar set of red flags: a suspicious link, a misspelled domain, an urgent request for a wire transfer. That approach is now colliding with an attacker toolkit that has changed faster than most awareness programs have. Generative AI has made it possible to clone a voice from a few seconds of audio, generate a passable deepfake video in minutes, and write a phishing email tailored to a specific employee's role, manager, and recent LinkedIn activity. Vishing calls, smishing texts, and video-based impersonation are now standard components of enterprise social engineering campaigns, not edge cases. "Most organizations are still training people to recognize threats from five years ago," said Tal Shlomo, co-founder and CEO of Frame Security, a huma
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom