The double-blind, placebo-controlled study is designed to evaluate the safety of BB3 for the treatment of heart attack (acute myocardial infarction) in conjunction with standard-of-care and its efficacy in improving heart function in patients who have experienced a first heart attack.
The trial will randomise 80 patients in 1:1 with either BB3 or placebo. Efficacy endpoints include myocardial infarct size, end diastolic volume, and left ventricular ejection fraction.
Yale New Haven Hospital principal investigator and Yale School of Medicine associate professor of medicine Frank Giordano said the hospital believes that BB3 is a promising therapy for the treatment of acute myocardial infarction.
"This trial will provide valuable data not only on the safety of BB3 in this population, but also whether this molecule can preserve heart muscle, promote beneficial healing of the heart, and improve clinical outcomes in patients suffering acute myocardial infarction," Giordano added.
BB3 is a small molecule mimetic of hepatocyte growth factor (HGF) that has been formulated for intravenous infusion and oral administration, according to the company.