Angion Biomedica has initiated Phase II of multicentre trial 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 had their first heart attack.
The first patient of the double-blind, placebo-controlled study, which is expected to enrol 80 patients, was treated at Yale-New Haven Hospital, Connecticut, US.
The trial is designed to randomise 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 believed that BB3 was 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 said.
BB3 is a small molecule mimetic of hepatocyte growth factor (HGF), which has been formulated for intravenous infusion and oral administration, according to the company.
In preclinical studies, BB3 has demonstrated the ability to not only protect healthy cells surrounding the heart tissue from dying, but also the capactiy to promote tissue regeneration following a heart attack.
Angion Biomedica Itzhak Goldberg said: "This exciting study will provide key insights as to whether the encouraging data we generated in preclinical models will translate to patient benefit."