First Patient Treated in Angion Biomedica Corp.'s Phase II BB3 Heart Attack Clinical Trial
Published: Jul 19, 2012
BB3 is a proprietary small molecule mimetic of hepatocyte growth factor (HGF). During a heart attack, the blood supply to part of the heart is interrupted, causing the surrounding cardiac tissue to die, impairing cardiac function. Subsequently, the healing process leads to chronically diminished pump function as scar tissue replaces damaged muscle. In preclinical studies, BB3 has the ability to not only protect healthy cells from dying, but also the ability to promote tissue regeneration following a heart attack.
“We are delighted to be part of this study and to have enrolled and treated the first patient,” said Frank Giordano, M.D., Associate Professor of Medicine at Yale School of Medicine and Principal Investigator at Yale New Haven Hospital. “We believe BB3 to be 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.”
“There is strong experimental evidence that the growth factor HGF can act as a modulator of cardiac repair”, said Dr. Alexandra Lansky, MD, FESC, FACC, Associate Professor of Medicine at Yale School of Medicine. “We are optimistic about Angion’s approach.”
“Initiating this heart attack trial is a very important milestone for Angion," said Itzhak D. Goldberg, M.D., F.A.C.R., CEO of Angion Biomedica. “This exciting study will provide key insights as to whether the encouraging data we generated in preclinical models will translate to patient benefit.”
About the Phase II Acute Myocardial Infarction Trial
This Phase II double-blind, placebo-controlled multicenter trial will evaluate the safety of BB3 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 be conducted at leading clinical centers in the United States. The target enrollment is 80 patients, and patients will be randomized 1:1 to either BB3 or placebo. Efficacy endpoints include myocardial infarct size, end diastolic volume, and left ventricular ejection fraction. More details about the trial can be found at http://clinicaltrials.gov/ct2/show/NCT01539590?term=BB3&rank=1.
BB3 is a small molecule mimetic of HGF that has been formulated for intravenous infusion and oral administration. BB3 has been granted Fast Track and Orphan Drug status by FDA for renal transplantation. It is currently being evaluated in two Phase II clinical trials in renal recipients in the United States and Europe, as well as a Phase I study in patients with liver fibrosis. The enrollment of healthy volunteers in a Phase I clinical trial designed to look at the safety and pharmacokinetics of BB3 oral formulation has just been completed.
About Angion Biomedica Corp.
Angion Biomedica Corp. is a biopharmaceutical company founded in 1998 focused on discovery and development of drugs that harness the body’s protective, reparative and regenerative systems for therapeutic benefit. The Company’s fully integrated, multidisciplinary research and development facility is located in Uniondale (Long Island), NY. The Company’s drug discovery and development platform utilizes state-of-the-art, fully-integrated molecular modeling, medicinal chemistry and preclinical biology capabilities to identify and optimize small molecule and peptide-based drug candidates. Angion Biomedica’s efforts have yielded a rich and diverse clinical and preclinical pipeline comprising novel HGF and other kinase modulators, PARP-1 inhibitors, retinoic acid signaling modulators and anti-fibrosis therapeutics. Issued and pending U.S and international patents allow Angion Biomedica to retain worldwide rights to its proprietary molecules and uses for clinical benefit. Please obtain further information at www.angion.com or contact Angion Biomedica at email@example.com.