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RELEASE: A clinical trial with psilocybin sponsored by Clairvoyant Therapeutics reaches 90% randomization

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RELEASE: A clinical trial with psilocybin sponsored by Clairvoyant Therapeutics reaches 90% randomization

(Information sent by the signatory company)

Clairvoyant, in the spotlight, for the possible commercialization of psilocybin treatment in 2025

Vancouver, April 4, 2024 - Clairvoyant Therapeutics Inc. (www.clairvoyantrx.com), the privately held clinical-stage pharmaceutical company developing a psilocybin treatment for alcohol use disorder (AUD), today announced that it is on track to become the first in the world to commercialize a clinically validated psilocybin treatment. Clairvoyant believes it could reach this milestone in the second half of 2025. Clairvoyant's randomized controlled trial, CLA-PSY-201, has dosed more than 90% of the 128 subjects planned for its 24-week Phase 2b clinical trial. synthetic psilocybin treatment for ADHD (two dosing sessions of one 25 mg oral capsule for 8 weeks) at 12 active clinical sites in Canada and Europe. Clinical trial results are expected to be available in the third quarter of 2024 and a series A funding round is currently underway. "We are rapidly approaching a critical and exciting time for psilocybin and its potential use as a treatment." recognized," said Damian Kettlewell, CEO of Clairvoyant. "We have compelling efficacy and safety data for 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 that "There is a regulatory pathway for conditional marketing authorization in Canada in 2025 and in the EU in 2026," he added. Conditional marketing authorization for psilocybin would be based on the recognition of AUD as a serious, life-threatening or severely debilitating disease. for which psilocybin demonstrates a significant increase in efficacy relative to existing ED medications. The conditional authorization of a new drug, known as NOC/c in Canada and CMA in Europe, allows the marketing of a new drug on the condition that the sponsor conducts additional studies to verify clinical benefit. Under the NOC/c and the CMA, companies are required to conduct confirmatory studies to validate initial evidence of efficacy. Clairvoyant intends to launch a pivotal confirmatory trial in H2 2025, with a readout in 2027, to support full approval of psilocybin treatment in Canada, the EU and the UK.About patient safetyClairvoyant is committed to ensuring safety and well-being of participants. Participants receive support from two therapists in preparation for and during the psilocybin-induced psychedelic experience. Clairvoyant has trained over 50 therapists in its 35-hour training program. Therapists are monitored for compliance with trial protocol and ethics under Clairvoyant's industry-leading Therapist Compliance Monitoring Program. No ethical issues have been identified to date.About Alcohol Use DisorderAlcohol is the leading risk factor for the global burden of disease among men and a significant risk factor among women[ii] A regional study recently reported that less than 5% of patients diagnosed with moderate to severe alcohol use disorder receive recommended medication[iii].About Clairvoyant TherapeuticsClairvoyant Therapeutics is a Canadian biotechnology company paving the way for global mental health through psilocybin treatment. Clairvoyant's rapid clinical strategy is designed to enable psilocybin treatment in Canada, the EU and the UK for patients with Alcohol Use Disorder (ADD) starting in 2025. The company's exceptional team, with deep experience in clinical development, has made Clairvoyant the most advanced company in the development of psilocybin for the treatment of AUD. Clairvoyant is a member of Life Sciences BC. More information about the Clairvoyant clinical trial can be found at ClinicalTrials.govBibliography / Webgrafia[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

ContactContact name: Damian KettlewellContact description: CEOContact phone: 1 778 747 3989