The Core of Neurodegeneration

GoodCap is dedicated to pioneering innovative therapeutic formulations for the treatment of psychiatric and neurodegenerative disorders. Our strategies are centered on addressing the fundamental pathological mechanisms that underlie these conditions, which encompass the intracellular accumulation of neurotoxic substances and the consequent persistent neuroinflammation. These processes can not only trigger but also fuel progressive neurodegeneration.

By prioritizing these foundational mechanisms, GoodCap’s therapeutic candidates aim to disrupt the harmful cycle of neuroinflammation and neurodegeneration that drives disease progression. Through this approach, our therapeutic candidates hold promise for broad applications spanning a wide spectrum of neuroinflammation-based psychiatric and degenerative disorders.

Chronic Neuroinflammation

Chronic neuroinflammation triggers increases in pro-inflammatory cytokines and reactive oxygen species, which can lead to a variety of psychiatric disorders and neurogenerative diseases

GCAP001: GoodCap’s Unique Approach​

Polymodal Activity

Targeting multiple clinically important biological pathways to downregulate IL-1β, IL-6, TNF-α, COX-2, and ROS

Known Biological Activity & Safety Profile

Utilize molecules that have known mechanisms and have established and attractive safety profiles.

Expediting Route to Clinic

Leveraging the safety profile of the formulation components to move into human trials quicker than NCEs

IP: Seeking CoM Coverage

Novel combination of molecule classes allows GoodCap to apply for composition of matter (CoM) coverage in the U.S. and internationally

Enhanced activity of GCAP001 on Inflammation

GoodCap’s lead therapeutic candidate is shown to significantly downregulate key pro-inflammatory cytokines

GCAP on inflammation final

Redefining PTSD Therapy for the Future​

Leveraging the profound insights from a decade of dedicated research and interaction with military veterans, GoodCap has identified critical gaps in mental health treatments, particularly for conditions like PTSD, depression, and anxiety. Inspired by this need for a more effective and comprehensive approach, we are on the forefront of developing advanced therapeutic formulations. 

Our focus remains steadfast on transcending traditional treatment methodologies to deliver a novel drug product. With every advancement, GoodCap reinforces its commitment to transforming the landscape of treatment by pioneering deeper understanding and more effective combat against neuroinflammatory and neurodegenerative disorders.

GoodCap’s co-founders have observed the significant impact of their drug prototypes, demonstrating remarkable outcomes in veterans afflicted with PTSD. This success has steered GoodCap’s commitment to empowering these individuals to reclaim their lives.

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:
An international, scientific, peer-reviewed, open access journal on molecular biology

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

Psilocybin and Eugenol Reduce Inflammation in Human 3D EpiIntestinal Tissue

Abstract

Inflammation plays a pivotal role in the development and progression of inflammatory bowel disease (IBD), by contributing to tissue damage and exacerbating the immune response. The investigation of serotonin receptor 2A (5-HT2A) ligands and transient receptor potential (TRP) channel ligands is of significant interest due to their potential to modulate key inflammatory pathways, mitigate the pathological effects of inflammation, and offer new avenues for therapeutic interventions in IBD. This study investigates the anti-inflammatory effects of 5-HT2A ligands, including psilocybin, 4-AcO-DMT, and ketanserin, in combination with TRP channel ligands, including capsaicin, curcumin, and eugenol, on the inflammatory response induced by tumor necrosis factor (TNF)-α and interferon (IFN)-γ in human 3D EpiIntestinal tissue. Enzyme-linked immunosorbent assay was used to assess the expression of pro-inflammatory markers TNF-α, IFN-γ, IL-6, IL-8, MCP-1, and GM-CSF. Our results show that psilocybin, 4-AcO-DMT, and eugenol significantly reduce TNF-α and IFN-γ levels, while capsaicin and curcumin decrease these markers to a lesser extent. Psilocybin effectively lowers IL-6 and IL-8 levels, but curcumin, capsaicin, and 4-AcO-DMT have limited effects on these markers. In addition, psilocybin can significantly decrease MCP-1 and GM-CSF levels. While ketanserin lowers IL-6 and GM-CSF levels, there are no effects seen on TNF-α, IFN-γ, IL-8, or MCP-1. Although synergistic effects between 5-HT2A and TRP channel ligands are minimal in this study, the results provide further evidence of the anti-inflammatory effects of psilocybin and eugenol. Further research is needed to understand the mechanisms of action and the feasibility of using these compounds as anti-inflammatory therapies for conditions like IBD.

Published in:

Life 202313(12), 2345

Psilocybin and eugenol prevent DSS-induced neuroinflammation in mice

Abstract

Neuroinflammation has emerged as a central pathology common to several acute and chronic brain diseases. Recent studies have displayed the anti-inflammatory properties of naturally occurring compounds derived from mushrooms and plants could potentially reduce neuroinflammation and disease progression. In this study, we aimed to investigate the impact of psilocybin and eugenol, as well as their combinations, on neuroinflammation. To induce inflammation through the gut-brain axis, we employed a colitis mouse model via oral feeding of dextran sulfate sodium (DSS). By administering various concentrations and combinations of treatments, both before and after inducing inflammation, we sought to assess the synergistic anti-inflammatory effects of psilocybin and eugenol. Our findings revealed oral psilocybin and eugenol post-treatment significantly reduced the expression of pro-inflammatory cytokines and inflammatory mediators in the brain, including IL-1β, IL-6, and COX-2. Notably, combined treatment of psilocybin and eugenol exhibited the strongest reduction in IL-6 levels when compared to the DSS group. While both psilocybin and eugenol possess anti-inflammatory effects, the combined treatment overall did not demonstrate synergistic reductions in neuroinflammation across all markers. This study
adds to the growing body of evidence supporting the therapeutic potential of psilocybin and
eugenol in psychiatric and neurodegenerative inflammatory disorders. Further research is necessary to elucidate the underlying mechanisms of their anti-inflammatory effects and to evaluate their efficacy in clinical settings.

Published in:

Biocatalysis and Agricultural Biotechnology 2024, 56, February 2024, 103033

Intellectual Property

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

H.G.J.M. Vermetten PhD, MD

Clinical psychiatrist and Faculty member of the Department of Psychiatry at Leiden University in the Netherlands with 20+ years of experience working with veterans and other uniformed officers as Head of Research at the Military Mental Health Service with the Dutch Ministry of Defense and was affiliated with ARQ National Psychotrauma Center. He also has an Adjunct Professorship at the Department of Psychiatry of New York UMC.

Author of 300+ scientific papers and 40+ book chapters, plus additional book edits. Leading the landmark 10-year PRISMO study on military operations, he offered insights into PTSD. 

Trained in the Netherlands as well as in the USA in psychiatry and neuroscience (Stanford, Yale, and Emory University). He has a clinical as well as a research position with a focus on medical/biological as well as psychiatric aspects of complex psychotrauma in military as well as civilian populations. Renowned for pioneering work in novel drug developments, particularly MDMA, psilocybin, ketamine, and medical cannabis.

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

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

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)

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

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.

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