Clairvoyant Therapeutics
On Track for Potential Commercialization of Clinically Validated Psilocybin Treatment in 2025
ABOUT US
Clairvoyant Therapeutics is a clinical stage biotechnology company changing the face of psychedelic therapy with a speed-to-market clinical strategy designed to enable psilocybin treatment in Canada and the EU to treat patients living with Alcohol Use Disorder (AUD) beginning in 2025.
The company’s exceptional team, with a proven clinical track record and deep drug development experience, has made Clairvoyant the most advanced company globally developing psilocybin therapy for the treatment of AUD.
Clairvoyant is operating a multi-country multi-site phase 2b psilocybin therapy randomized controlled trial for AUD.
Clairvoyant is a member of Life Sciences BC.
Welcome.
PSILOCYBIN FOR PATIENTS
Compelling clinical research data to date have demonstrated the transformative nature of psilocybin drug treatment to help patients suffering with substance use disorders and significant mental health conditions.
The novel combination of psilocybin drug administration in the presence of a trained counsellor is a paradigm shift for the substance abuse disorder and mental health treatment sector. These patients have had no significant new treatment options offered to them for a number of decades.
Our Team
Clairvoyant has assembled an industry leading team and our clinical team has an average 20 years of pharmaceutical drug development experience.
Directors
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Damian Kettlewell
CEO, CO-FOUNDER & DIRECTOR
Successful entrepreneur creating, operating and scaling companies
Experienced in regulatory affairs, government relations, international and capital markets
Exited prior company in 2019 with $48M sale
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Alex Kuznetsov
DIRECTOR
Managing Partner at Kodori AG, leading early-stage venture deals with a focus on mental health innovations and psychedelics
Startup board governance and psychiatric clinical experience
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Dustin Robinson
DIRECTOR
Founder of psychedelic venture capital firm Iter Investments and top psychedelic advocacy group Mr. Psychedelic Law.
Licensed attorney and CPA & expert in understanding & capitalizing on opportunities within highly regulated industries.
Management
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Thomas Digby
CO-FOUNDER, LEGAL COUNSEL & IP STRATEGY LEAD
25+ years in practice as a US and Canadian IP and transaction attorney
Has advised a wide range of clients, from seed-stage, VC-funded startups through to global pharma companies
Expertise in license and M&A, negotiation & dispute resolution
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Long Trinh
FRACTIONAL CFO
Successful entrepreneur, accountant and 15+ years of international business experience
Raised $15m for prior start up and exited through a RTO transaction
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Lynn Murray
DIRECTOR, CLINICAL OPERATIONS
20+ years of experience operating phase 2 and phase 3 clinical trials
Supporting registration efforts with the health authorities in Europe and North America
Passionate about working in the field of clinical research
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Ali Ardakani
CORPORATE DEVELOPMENT
20+ years life sciences development
Multiple INDs and 510(k) approvals
Partnership with several large multi-nationals
Multiple M&As and raised $100 MM+
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Clare Plumtree
DIRECTOR, CLINICAL SUPPLIES
12+ years clinical supplies expertise for Phases I-III studies covering all aspects of supply management across multiple therapeutic areas
Global experience with extensive knowledge of GCP, ICH and FDA guidelines
Key subject matter expert during regulatory audits
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Colin D. Funk, PhD
SCIENCE OFFICER
25+ years as NIH and CIHR-funded, highly cited, a biomedical research scientist at three world-renowned institutions
Extensive background in establishing, developing, and leading university-industry research partnerships
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Patrick Tam, PhD
CLINICAL & REGULATORY ADVISOR
20 + years life sciences development
Track record of successful completion of preclinical, IND, and NDA projects
Expertise in early-phase drug development, pharmacology, toxicology, bioanalytical method development & validation & clinical pharmacology
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Darcie Stuart
PARALEGAL
25+ years of experience in Contract Drafting, Negotiation, Planning, Policy, Process and Stakeholder Management
15+ years experience in life sciences contracting (pre-clinical, clinical trials and commercialized products).
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Sean Ty
FINANCE
Extensive experience in both publicly and privately-owned companies
Assisted numerous companies with financing and obtaining a listing status in the capital markets
Previously an Assurance Manager at a Big 4 accounting firm
Advisors
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Alyssa Forcehimes, PhD
PSYCHOTHERAPY CONSULTANT
Experienced clinical therapist for psilocybin therapy and addiction trials
Addiction clinical trial design consultant
Psychotherapist training specialist
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Tom Rossi
COMMERICALIZATION & SCALING UP ADVISOR
30+ years commercialization & executive management experience in life sciences
Former Acerus Pharmaceutical CEO and Novartis Pharma Country President & CEO (Canada; Belgium & Luxembourg)
Extensive experience in leading large pharmaceutical organizations across wide variety of therapeutic areas as well as a publicly traded, specialty pharma start-up
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Rami El-Cheikh
CORPORATE STRATEGY & VALUE CREATION ADVISOR
20+ years experience in growth strategy, value creation and M&A consulting
Orchestrated several large (>$1B) transactions in life sciences sector
Extensive experience in the controlled substances space in the US and Canada
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Brent Korte
HEALTH ECONOMICS & REIMBURSEMENT LEAD
25+ years reimbursement strategy, market access & sales experience
Managed national market access team with responsibility for public, private and federal plans across Canada
22 years with Janssen Pharmaceutical of Johnson & Johnson
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Kamy Doray
OPERATIONS ADVISOR
Knowledgeable operations advisor with experience in neuroscience, healthcare, psychology and research
BAS in Neuroscience and Psychology with distinction from the University of Guelph
Extensive experience in clinical research methods, knowledge translation, and data analysis
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Stewart Seidman
PSYCHIATRY & PSYCHOPHARMACOLOGY ADVISOR
Owns a psychiatric clinic in NYC
Teaches psychiatry at the Chaim Sheba Medical Center
CLAIRVOYANT’S REGULATORY STRATEGY
Clairvoyant is focused on the clinical validation of psilocybin in Canada, the EU and the UK.
Our regulatory strategy is to obtain approval in alcohol use disorder (AUD) and to expand into other substance abuse disorder indications in parallel:
Alcohol is the leading risk factor for overall burden of disease among men and a significant risk factor among women.¹
According to the World Health Organization, 283 million people aged 15 years and older are at risk of AUD.²
Globally, mortality for alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS, and diabetes.²
A regional study recently reported that fewer than 5 per cent of patients diagnosed with moderate to severe alcohol use disorder receive recommended medications.³
Randomized Clinical Trial data published in 2022 in JAMA Psychiatry showed that two doses of psilocybin reduce heavy drinking by 83 per cent on average among heavy drinkers when combined with psychotherapy. This 2022 data is supported by a psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study in 2015.
These encouraging clinical trial results related to the use of psilocybin for the treatment of AUD help validate Clairvoyant’s own clinical trial approach.
Support for the use of psilocybin as a therapeutic agent is growing and we plan to expand into other substance abuse disorder indications.
CLAIRVOYANT’S CLINICAL TRIAL (CLA-PSY-201)
CLA-PSY-201 is a 24-week Phase 2b clinical trial of synthetic psilocybin treatment for AUD (two dosing sessions of 25 mg oral capsule over 8 weeks) at 12 active clinical sites in Canada and Europe.
See further info on our trial at clinicaltrials.gov listing here.
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. 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.
PRESS RELEASES
Clairvoyant on Target for Potential Commercialization of Psilocybin Treatment in 2025
April 3, 2024
Clairvoyant Surpasses 50 Per Cent Randomization in its Phase 2b Psilocybin Therapy Trial for Alcohol Use Disorder
November 29, 2023
First Patient Dosed in CLAIRVOYANT’s Phase 2b Clinical Trial Exploring Psilocybin as a Treatment for Alcohol Use Disorder
November 3, 2022
CLAIRVOYANT’S Phase 2b Psilocybin Therapy Trial For Alcohol Use Disorder Obtains Regulatory Approval and Initiates 1st Site in FINLAND October 13, 2022
CLAIRVOYANT Initiates First Site for Phase 2b Psilocybin Therapy Clinical Trial for Alcohol Use Disorder July 6, 2022
CLAIRVOYANT THERAPEUTICS Receives Approval in Canada to Initiate a World-Leading Psilocybin Trial for Treatment of Alcohol Use Disorder January 20, 2022
CLAIRVOYANT THERAPEUTICS Raises More Than $3 Million in Seed Financing, Adds Bench Strength to Senior Team
November 30, 2021
CLAIRVOYANT Expands Team with Director Greg Engel and CFO Long Trinh
October 6, 2021
Media
NORTH AMERICA
EUROPE
Clairvoyant Presenting at EU Parliament
Regulatory Pathways for Psychedelic Therapies, November 6, 2023
CAREERS
We have completed our hiring at this time. Please connect with us below if you are interested in joining the Clairvoyant team.
Call: +1 778 747 3989
Clairvoyant Therapeutics Inc.
#2400 - 1055 West Georgia Street
Vancouver, BC
V6E 3P3
Canada
References
¹ Bogenschutz, MP et al. (2022) JAMA Psychiatry. 2022;79(10):953-962. doi:10.1001/jamapsychiatry.2022.2096
² World Health Organization. Global Status Report on Alcohol and Health 2014 Accessed March 2024 at WHO Global Status Report on Alcohol and Health 2014
³ 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