EA-230
Phase 2 clinical trial currently ongoing
Following approval from German and Dutch regulatory authorities, in May 2009 screening of patients for enrollment in a Phase 2 clinical trial at Hannover University Medical Center, Germany was initiated. The exploratory 150-patient study is designed to assess the effects of EA-230 on renal function and on safety and tolerability in patients at increased risk of developing renal failure following major on-pump cardiac surgery. The Company is planning to add an additional site to accelerate the recruitment process.
Phase 1 single and multi-dose clinical trials have been successfully completed
Human volunteers were administered increasing single doses of the company’s compound EA-230. All the doses were tolerated without significant adverse events. Subsequently, volunteers were administered multiple doses over several days, again without adverse events.
Phase 1 expansion – LPS Proof of Concept has been successfully completed
In order to obtain data on whether EA-230 will be efficacious as well as safe in sepsis patients, the Phase 1 trials were expanded into an additional study design. The optimum dose, as determined by the pre-clinical data and the safety phase of the human volunteer studies, was given to another set of healthy volunteers who were all exposed to a fixed dose infusion of lipopolysaccharide (“LPS”), otherwise known as endotoxin. In normal infections from a certain group of bacteria (Gram negative micro-organisms), as the bacteria are disrupted and killed, their cell walls release LPS. The infected patient responds to this substance with a series of reactions such as chills and fever, change in blood pressure, heart arrhythmia, etc. It is this set of reactions that can ultimately lead to septic shock and death.
Therefore, it was important for the Company to determine whether EA-230 could counter the effects of LPS in human volunteers. If so, the likelihood of success in sepsis patients enrolled in a Phase 2 trial would be increased. All volunteers received the LPS, but the control subjects received only a placebo, while the test subjects were infused with EA-230. As the study progressed, it was clear that the Company’s drug was having the desired effect. A variety of reactions caused by LPS were countered by the drug. Importantly, these reactions were not only physically observable, such as control of fever, but also biochemically detectable, such as changes in several chemical substances in the body that are associated with inflammation in sepsis.