EBI’s lead product is based on one of the polypeptide compounds derived from the human pregnancy hormone and is currently progressing through the clinical development phases.
EBI has recently completed a placebo-controlled, combined phase IIa and phase IIb clinical study with patients undergoing elective CABG‐surgery (n=180). During surgery, the circulation of the patients was maintained using cardiopulmonary bypass. In this trial the effect of EBI’s lead compound on renal function in patients at increased risk of developing renal failure was assessed.
The study showed treatment with EA-230 to be effective in reducing post-operative length-of-stay in the Intensive Care Unit, improving hemodynamic stability and therewith preventing fluid overloads in patients undergoing elective CABG surgery. Also, a significant overall improvement of kidney function was found. Moreover, this beneficial reduction of length-of-stay did not increase re-admission risk.
These positive results follow proven efficacy in providing protection for multiple organ damage and death in a large variety of preclinical models, and safety and tolerability in single escalating dose Phase I studies.
EBI is currently laying the groundwork for a pivotal Phase 3 clinical trial. As EA-230 is a first-in-class peptide drug with significant and beneficial hemodynamic and renal effects, a pivotal Phase 3 clinical trial will focus on the capacities of EA-230 to improve blood-vessel permeability and contractility under various conditions of surgery and intensive care.
Primary output parameters of such a Phase 3 trial will include length-of-stay at ICU and Hospital and renal function. These clinical endpoints will be monitored by observing hemodynamic and inflammatory marker levels in the patients treated with EA-230 or placebo.
After successful completion of the Phase 3 trial, EBI aims at applying for market authorization.