Mental Health is a Global Crisis

The prevalence of mental health disorders is increasing rapidly, and there are significant unmet needs in this area. The estimated prevalence of PTSD globally is 308 million people, with an associated economic burden of $2.5 trillion.

The current approach to mental health care is insufficient to address this growing problem. Most patients do not respond to the first drug prescribed, which leads to prolonged suffering and imposes significant medical, societal, and economic costs. Conditions like PTSD have few approved medications, leaving patients with limited treatment options. 

GoodCap’s transformative drug candidate is set to disrupt the traditional pharmaceutical landscape, breaking barriers in the anti-depressant, NSAID and opioid sectors.

Missing the Mark

Emerging research indicates PTSD patients exhibit a variety of imbalanced physical markers which current drug treatments do not effectively treat. Additionally, many drug development efforts fail to recognize or accommodate for the enormous cost and access issues inherent in large doses of psychedelics. There is a significant unmet need for better treatment options for mental health disorders. To address this issue, it is critical to develop innovative new therapies that can account for individual variability and improve outcomes for patients. 

PTSD

Breakthrough meta-analyses of clinical data indicates the underlying root causes of PTSD symptoms in patients are inflammation and oxidative stress

Trauma

Root Biological Responses

Inflammation Levels
Oxidative Stress

Long-term PTSD Effects

Chronic Inflammation & Oxidative Stress

 

Compromised Neuronal/Hormone Pathways

 

Cardiovascular Disease

Metabolic/Mitochondrial Dysregulation

 

Gut Microbiome Issues

 

Chronic Pain

 

Figure modified from Muhie, Seid, et al. “Molecular signatures of post-traumatic stress disorder in war-zone-exposed veteran and active-duty soldiers.” Cell Reports Medicine 4.5 (2023).

Lead Drug Candidate: GCAP001

Combining Eugenol and Psilocybin

Designing drug products whose active pharmaceutical ingredients provide additive therapeutic effects while targeting multiple clinically important biological pathways  

Drug Safety

Utilizing molecules with established and attractive safety profiles

Patient Access

Developing treatments with benefits over classic psychedelic therapies, including:

  • Avoiding the need for professional oversight during the dosing event
  • Avoidance of patient intoxication
  • Limiting adverse events

Publications & IP

Abstract

Acute and chronic inflammation of the body triggers the production of pro- and anti-inflammatory pathways that can affect the content of cytokines in the brain and thus cause brain inflammation. Disorders such as depression and posttraumatic stress disorder (PTSD) are often associated with elevated inflammation. Recently, positive and promising clinical results of psilocybin for the treatment of depression and PTSD were reported. Thus, we decided to test whether psilocybin alone or in combination with eugenol, an anti-inflammatory and antioxidant agent, would prevent the increase in or decrease the content of cytokines in the brain…

This demonstrates the anti-inflammatory effects of a combination of psilocybin and eugenol in the brain of animals with systemically induced inflammation.

Published in:

The leading international, peer-reviewed, open access journal of chemistry.

Molecules, March 2023, 28(6), 2624;

Abstract

Intestinal inflammation and dysbiosis can lead to inflammatory bowel diseases (IBD) and systemic inflammation, affecting multiple organs. Developing novel anti-inflammatory therapeutics is crucial for preventing IBD progression. Serotonin receptor type 2A (5-HT2A) ligands, including psilocybin (Psi), 4-Acetoxy-N,N-dimethyltryptamine (4-AcO-DMT), and ketanserin (Ket), along with transient receptor potential (TRP) channel ligands like capsaicin (Cap), curcumin (Cur), and eugenol (Eug), show promise as anti-inflammatory agents. […] This study is the first to explore the anti-inflammatory potential of psilocybin and 4-AcO-DMT in the intestines while highlighting the potential for synergy between the 5-HT2A and TRP channel ligands, specifically Psi and Eug, in alleviating the TNF-α/IFN-γ-induced inflammatory response in HSEIC. Further investigations should evaluate if the Psi and Eug combination has the therapeutic potential to treat IBD in vivo.

Published in:

The leading international, peer-reviewed, open access journal of chemistry.

Current Issues Molecular Biology, August 2023, 45 (8), 6743-6774.

Patent Application

 

“Compositions for Reducing Inflammation to Improve or Maintain Mental or Physical Health”

Claims capture both composition of matter and methods of use

Captures classes of molecules (TRP receptor agonists and 5HT2a receptor agonists) in various combinations including those in GCAP001

Provides wide range of pipeline opportunities via formulation modifications to target additional inflammation-based disease states including mood disorders, pain, digestive problems, substance abuse and cancer

Priority Date: October 11, 2020

Barbara Olasov Rothbaum, PhD, MD

Clinical researcher in Atlanta, USA with 37+ years of experience in medical practice, teaching, and research focused on Post-Traumatic Stress Disorder.

Author of 400+ scientific papers and chapters and served as Associate Editor of The Journal of Traumatic Stress.

Blue Ribbon Panel Member for Pentagon officials, consultant to the Department of Defense, and Member of the Institute of Medicine’s (IOM) Study on Assessment of Ongoing Efforts in the Treatment of PTSD

Professor of Psychiatry and Behavioral Sciences at the medical school of a high-ranking University in Atlanta, where she is a director of the Trauma and Anxiety Recovery Program and the Associate Vice Chair of Clinical Research.

Carol Coughlin, MBA

Director, Chair of FAR Committee

 

20+ years experience as CFO specializing in healthcare

Experienced public company board leader, audit committee chair, and is highly skilled in corporate governance including board refreshment, strategic alternatives and M&A for growth and highly regulated companies

Loyola University in MD (MBA) and Towson University (BS Business), is a Board Leadership Fellow (NACD) and a Certified Public Accountant (active status)

Portrait of Dr. Daryl Hudson

Darryl Hudson

Co-founder and Chief Innovation Officer

 

Deep expertise in molecular biology, neuroscience and genetics in psychedelics

Prior to founding GoodCap, Darryl co-founded InPlanta Biotechnology Inc. and Pathways Rx, where he led the development and commercialization of proprietary plant genetics

PhD in molecular biology and genetics from the University of Guelph

Ralph Landau

Chief Science Officer

 

30+ years executive leadership in pharmaceutical R&D, manufacturing and operations

Sandoz, Novartis, Merck, Elan, Fougera, Cambrex

Led the commercialization of over 50 products covering a number of dosage forms, including Veregen, the first ever botanical drug approved by the FDA

Ph.D., Chemical Engineering, from the University of Delaware

Bachelor of Science, Chemical Engineering, from the New Jersey Institute of Technology

Andrew Williams, MBA

Chief Financial Officer

 

17+ years in the Pharma/Biotech sector as a Chief Financial Officer with extensive start-up, strategic, financial and operational experience

Was the COO & CFO of Cynapsus Therapeutics, a specialty CNS pharmaceutical company that developed Kynmobi®, a sublingual thin film strip for the treatment of OFF episodes associated with Parkinson’s disease

In October 2016, Cynapsus was acquired for $841 million by Sunovion Pharmaceuticals

While serving as CFO, Cynapsus raised approximately $170 million via private and public offerings, including $90 million from the proceeds of a US Initial Public Offering and NASDAQ listing.

BAH Economics from Queen’s University and MBA from Ivey School of Business at Western University

Rochelle Stenzler, BSc Phm, ICD.D

Chair of Board

 

35+ years senior executive and board experience in Pharma/healthcare

Fmr. President/CEO Pharma Plus Drugmarts, Revlon Canada, TLC Laser Eye Centers and TouchLogic Corporation

Chair of Cynapsus Therapeutics which was acquired for $841million

Fmr. Director & Vice Chair of the Humber River Hospital

BScPhm, Pharmacy, University of Toronto

Theresa Matkovits, PhD

Director

 

20+ years experience as leader in global drug development and commercialization

Experience across multiple therapeutic areas including Endocrine Disorders, Anti-infectives, Antivirals, Central Nervous System Disorders (Schizophrenia, Bipolar Disorders, Generalized Anxiety Disorders, Major Depression, Migraine, Anesthesia), Women’s Health, as well as a number of orphan indications

Board Director in private and public-sector companies

Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology, University of Medicine and Dentistry of New Jersey

Joseph Elliot, MSc, PhD

Director

 

More than 30 years as a serial entrepreneur and former venture capitalist

Broad experience pharmaceuticals, biologicals and vaccines in oncology and infectious diseases

Experienced in drug development, manufacturing, regulatory affairs (FDA, EMA, NICE, Health Canada, WHO and BfArM)

Held senior technical and international marketing positions with Pharmacia Canada Inc. (now Pfizer) and Connaught Laboratories Inc (now Sanofi-Pasteur Vaccines)

PhD in Medical Sciences from McMaster University

Lorne Gertner, BArch, ICD.D, MRIAC

Director

 

Serial entrepreneur at the lead of emerging industries

Co-founder of Cynapsus Therapeutics which was acquired for $841 million

Co-founded and is the former chairman of PharmaCan (later known as Cronos), which achieved a peak market capitalization of $7 billion

Co-founder of the Tokyo Smoke brand which is now owned by Canopy Growth after a purchase in 2018 for $542 million

Daniels Faculty of Architecture, Landscape, and Design at the University of Toronto

Robert Dantzer, PhD, DVM

Professor in the Department of Symptom Research in the Division of Internal Medicine at The University of Texas MD Anderson Cancer Center, Houston, Texas

A pioneer in establishing the connection between depression and inflammation

Current research aims at understanding the role of inflammation and mitochondrial dysfunction in the pathophysiology of depression and fatigue

Authored more than 550 original research papers, reviews and book chapters on stress, anxiety, neuropeptides, brain-immune interactions, and inflammation-associated depression

Charles B. Nemeroff, PhD, MD

Chair and professor with the Department of Psychiatry and Behavioral Sciences at the University of Texas at Austin

Co-director of the Center for Psychedelic Research and Therapy

Directs the Institute for Early Life Adversity Research within the Department of Psychiatry and Behavioral Sciences as part of the Mulva Clinic for the Neurosciences

Former Chair of the Department of Psychiatry and Behavioral Sciences and clinical director of the Center on Aging at the University of Miami Miller School of Medicine

Laura Targownik, PhD, MD

Clinician Researcher in the Mount Sinai Hospital Inflammatory Bowel Disease Clinic. Director for the University of Toronto Division of Gastroenterology and Hepatology and a faculty member of the University of Toronto School of Public Health Institute for Health Policy, Management and Evaluation.

Founder of the Ontario Best Practices Research Initiative in IBD, Ontario’s premier source of real-world data and patient-reported data on IBD in Ontario. Authored or co-authored over 180 articles in peer-reviewed publications.

Current research focus on the costs and benefits of medications used in IBD, assessing how to optimize delivery of mental health care for persons with IBD in diverse practice settings.

Elizabeth Nielson, PhD

Co-founder of Fluence and a psychologist with a focus on developing psychedelic medicines as empirically supported treatments for mood disorders, PTSD, and substance use problems. 

Site Co-Principal Investigator and therapist for an FDA approved Phase 3 clinical trial of psychedelic-assisted Psychotherapy and has served as a therapist on earlier FDA approved clinical trials of psilocybin-assisted treatments for treatment resistant depression. 

Assistant Professor of Clinical Medical Psychology in Psychiatry and Project Clinician at Columbia University where her research includes qualitative and mixed-methods projects to further understand the phenomenology and mechanisms of change in psychedelic-assisted therapy.

Ken Croitoru, PhD, MD

Professor of Medicine at the University of Toronto, where he is a member of the Institute of Medical Science and secondarily appointed to the Department of Immunology

Gastroenterologist and internist at Mount Sinai Hospital in Toronto, Canada with 35+ years of experience in medical practice, teaching, and research focused on gut inflammation

Worked extensively with the Crohn’s and Colitis Foundation of Canada where he helped to develop the IBD Research Institute, and is now a project leader of the GEM Project, a global clinical study coordinated out of the IBD research group at the Zane Cohen Centre at Mount Sinai Hospital

Cory Weissman, MD​

Head of Interventional Psychiatry at UC San Diego, focusing on the development of novel treatments, including psychedelic medicines, for patients with severe mental illness

Highly active in the field of psychedelic science, where he has published on psychedelic microdosing and led several studies investigating the potential use of psychedelics for suicidality

Former clinical and research fellow in brain stimulation at the University of Toronto 

Portrait of Steve Sadoff

Steven Sadoff

Co-founder and Chief Executive Officer

 

15+ years of leadership experience across highly regulated industries with 100+ innovative product launches

Proven track record of growing sales, building brands, and leading product-development teams for Bacardi, Labatt, Novartis, and Jamieson Laboratories