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.
Breakthrough meta-analyses of clinical data indicates the underlying root causes of PTSD symptoms in patients are inflammation and oxidative stress
Root Biological Responses
Long-term PTSD Effects
Chronic Inflammation & Oxidative Stress
Compromised Neuronal/Hormone Pathways
Gut Microbiome Issues
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
Utilizing molecules with established and attractive safety profiles
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
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.
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.
“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