REVOLUTIONIZING THE TREATMENT OF INFLUENZA
CytoAgents is a privately held biotechnology company focused on the development of innovative pharmaceutical products for the treatment of influenza and other viral infectious diseases. Using a novel, host-directed approach, we target the underlying cause of life- threatening symptoms associated with influenza and cytokine release 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.
A DEVASTATING PUBLIC HEALTH THREAT
New strains and combinations of influenza strains circulate every year. The major strains currently in circulation are in the H1N1, H5N1, and H3N2 subtypes. It is unclear why some strains induce mild or severe cases of influenza in most people, but in other cases induce severe cases of influenza with devastating results. In the spring of 2009, a new influenza virus was identified. Originally called “swine flu”, the new virus has been named “2009 H1N1”.
The cornerstone of influenza therapy is vaccination and anti-viral medications, both of which have significant limitations. During the 2017-2018 influenza season the CDC estimated roughly 960,000 hospitalizations and 80,000 deaths in the United States. Deaths from influenza are typically from respiratory symptoms. The respiratory symptoms are a result of the immune system producing cytokines which induce an inflammatory condition. Currently, there are no effective treatments to treat these respiratory symptoms associated with an average of 13M medical visits annually.
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 or “Cytokine Storm”, which is induced by influenza and other viral infections. Our approach to treatment focuses on reducing the destructive impact of the cytokine storm. CytoAgents' approach to therapy is significantly less susceptible to viral mutation and the development of viral resistance.
The excessive release of pro-inflammatory cytokines is described as a cytokine storm. The cytokine storm has been implicated by the high morbidity and mortality rates seen with infection with different strains of influenza including subtypes H5N1 (avian flu) and H1N1 (swine flu), as well as with Severe Acute Respiratory Syndrome (SARS) caused by the SARS-CoV virus. Because the symptoms of influenza and all ‘influenza-like-illness’ (ILI) can be associated with high levels of pro-inflammatory cytokines, the symptoms of all moderate and severe cases of influenza could be due to a cytokine storm. The cytokine storm can cause tissue damage and the accumulation of cell debris that can clog airways leading to a decrease in lung function and pneumonia.
CytoAgents’ lead candidate, GP1681, addresses a clear unmet need and will expand the category for therapy options available for the treatment of influenza. Additionally, given the mechanism of action, GP1681 may address other conditions associated with cytokine release syndrome. There is no therapy for influenza beyond the first 48 hours of influenza symptoms. According to the CDC, last year there were 23M medical visits, 960,000 hospitalizations and 80,000 deaths in the US from influenza. Currently, there are no viable treatment options for the majority of these patients. GP1681 will treat the symptoms by modulating the immune system (unlike anti-viral medications) throughout the course of influenza. Symptoms correlate with cytokine levels and GP1681 decrease the cytokine levels and therefore decrease mortality.
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.
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