REVOLUTIONIZING THE TREATMENT OF VIRAL EPIDEMICS
A RADICAL, INNOVATIVE WAY TO TREAT RESPIRATORY VIRUSES
CytoAgents is a privately held biotechnology company focused on the development of innovative pharmaceutical products for the treatment of COVID-19, Influenza and other viral infectious diseases. Using a novel, host-directed approach, we target the underlying cause of life-threatening symptoms associated with COVID-19, Influenza and Cytokine Releasing Syndrome by modulating the natural immune response to the disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future.
EPIDEMICS: ONGOING PUBLIC HEALTH THREAT
COVID-19 AND INFLUENZA
New strains and uniquely combined strains of influenza and other viruses circulate every year. It is unclear why some strains induce mild or severe cases of influenza in most people, but in other cases induce severe cases with devastating results. Although it is clear that age, genetics and underlying illness play important roles, it is also clear that in certain circumstances the virus can induce a powerful and counterproductive, excessive immune response causing severe respiratory distress. Progression to severe illness seems to hinge on this immune response referred to as Cytokine Release Syndrome or more commonly Cytokine Storm.
The cornerstone of viral therapy is vaccination and anti-viral medications, both of which have significant limitations. During the 2017-2018 influenza season, the CDC estimates roughly 960,000 hospitalizations and 80,000 deaths in the United States. Deaths from influenza are typically from respiratory symptoms. Currently, there are no effective treatments to combat these respiratory symptoms, leaving the world vulnerable to viral pandemics.
CytoAgents' lead drug candidate modulates the body's immune response to reduce tissue damage caused by an excessive immune reaction. This approach would decrease the tissue damage resulting from the excessive release of pro-inflammatory cytokines, known as the Cytokine Release Syndrome, which is induced by influenza and other viral infections. Our approach to treatment focuses on reducing the destructive impact of the Cytokine Release Syndrome. CytoAgents' approach to therapy is independent of viral mutation and the development of viral resistance and therefore the therapeutic benefit applies broadly to all diseases triggering Cytokine Release Syndrome.
The excessive release of pro-inflammatory cytokines from our immune system is described as a Cytokine Release Syndrome. Cytokine Release Syndrome is linked to the high morbidity and mortality rates seen with the different strains of Influenza including subtypes A, H5N1 A (Avian Flu) and H1N1 A (Swine Flu), Severe Acute Respiratory Syndrome (SARS) caused by the SARS-CoV virus and the current outbreak of COVID-19 caused by the SARS-CoV-2 virus. The Cytokine Release Syndrome can cause tissue damage and the accumulation of cell debris that can clog airways leading to decrease in lung function and pneumonia. Because the symptoms of severe influenza and all 'influenza-like-illness' (ILI) can be associated with high levels of pro-inflammatory cytokines, we see tremendous promise that the mechanism of action of GP1681 has promise broadly across all viral categories.
GP1681: ADDRESSING AN UNMET NEED
CytoAgents' lead candidate, GP1681, addresses a clear unmet need and will expand the category for therapy options available for the treatment of viral illnesses. The mechanism of action, fine-tuning the immune response by tamping down various cytokines, will enable the broad therapeutic benefit across a spectrum of illnesses associated with Cytokine Release Syndrome.
There is no therapy for influenza beyond the first 48 hours of symptoms. According to the CDC, during the 2017-2018 influenza season, there were 23M medical visits, 960,000 hospitalizations and 80,000 deaths in the US alone from influenza. The mortality and seasonality of COVID-19 remains to be seen. Symptoms correlate with cytokine levels, GP1681 decreases cytokine levels and therefore should decrease mortality. Our vision is to be a platform for seasonal influenza and epidemics impacting the world currently and well into the future.
GP1681, is an agonist of a G-protein coupled receptor (GPCR). The expression of this GPCR is dramatically increased during the activation and migration of white blood cells and plays a role in the anti-inflammatory response. GP1681 has been shown to reduce the release of pro-inflammatory cytokines and chemokines from activated, human white blood cells.
GP1681 has an FDA accepted Investigational New Drug (IND) application and is ready to start Phase I human clinical trials.