SAN FRANCISCO – May 5, 2020 – Angion Biomedica Corp. (Angion), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced the publication of a peer-reviewed article in the scientific journal Transplantation presenting results from its Phase 2 clinical trial of ANG-3777 in transplant-associated acute kidney injury. The publication, authored by Jonathan S. Bromberg, M.D., Ph.D., et al., is titled, “Renal Function Improvement Following ANG-3777 Treatment in Patients at High Risk for Delayed Graft Function after Kidney Transplantation.”
“We believe the publication of the Phase 2 data in Transplantation further validates ANG-3777 as a potential treatment for acute organ injuries such as transplant-associated acute kidney injury, also known as delayed graft function, a severe and potentially life-threatening condition without effective therapeutic options,” said Dr. Jay Venkatesan, Angion’s President and Chief Executive Officer. “Our enthusiasm around this program is supported by these Phase 2 results showing ANG-3777 was generally well-tolerated and led to clinically meaningful improvements as compared to placebo in several key endpoints, including eGFR. We look forward to further validating the therapeutic promise of ANG-3777 and reporting data from our ongoing Phase 3 registration trial of ANG-3777.”
This publication details the results of the administration of ANG-3777 in patients who have undergone deceased-donor kidney transplantation and had signs of kidney injury, placing them at high risk for delayed graft function. This Phase 2 clinical trial was a multi-center, randomized, double blind, placebo-controlled clinical trial. Subjects were patients receiving renal transplantation producing less than 50 cc of urine per hour for eight consecutive hours over the first 24 hours following transplantation, and/or demonstrating a creatinine reduction ratio <30% from pre-transplantation to 24 hours post-transplantation. Patients were randomized 2:1 to receive three once-daily intravenous infusions of ANG-3777 or placebo. The primary endpoint was number of days to producing > 1,200 cc of urine over 24 hours.
Jonathan Bromberg, M.D., Ph.D., Professor of Surgery and Microbiology and Immunology and Vice Chair for Research at University of Maryland and lead author of the publication added, “Our findings provide further support ANG-3777 has the potential to represent a significant improvement over current standard of care for patients in need of an effective therapeutic option.”
The full publication can be accessed at: https://doi.org/10.1097/tp.0000000000003255
About Delayed Graft Function
Delayed graft function (DGF) is a severe form of acute kidney injury resulting from ischemia-reperfusion injury following kidney transplantation. It is distinct from transplant rejection and is most commonly seen in recipients of deceased-donor kidneys, in part due to the longer periods of warm ischemia (ischemia occurring at body temperature) and cold ischemia (ischemia occurring during kidney preservation and transport) typical for deceased-donor kidney transplants. DGF is most commonly defined as the need for dialysis (the extracorporeal removal of waste products from the blood when the kidneys are in a state of failure) within seven days following transplantation. Patients who experience DGF have a reduction in transplant survival. There are currently no approved treatments to prevent or reduce the severity of DGF.
ANG-3777, is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), thereby activating the c-Met cascade of pathways involved in tissue repair and organ recovery. ANG-3777 has demonstrated several similarities to HGF, including c-Met dependence and selective c-Met receptor activation, without acting on other growth factor receptors. In addition, it has a substantially longer half-life than HGF. As a result, we believe ANG-3777 has the potential to be a first-in-class therapeutic with a unique approach to addressing acute organ injury because it has the ability to enhance key natural organ repair pathways, expand the treatment window after acute organ injury, and has had a favorable adverse event profile based upon data from early clinical trials. Enrollment is ongoing in a placebo-controlled Phase 3 registration trial examining the efficacy of ANG-3777 in DGF and in a Phase 2 clinical trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass.
About Angion Biomedica Corp.
Angion Biomedica Corp. is a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases. Angion’s lead product candidate, ANG-3777, is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF) to activate the HGF/c-Met pathway, which has a central role in tissue repair and organ recovery. Enrollment is ongoing in a placebo-controlled Phase 3 registration trial examining the efficacy of ANG-3777 in reducing the severity of transplant-associated acute kidney injury, also known as delayed graft function, in patients at risk for kidney dysfunction. ANG-3777 is also in a Phase 2 clinical trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass. Angion is also developing ANG-3070, an orally-bioavailable small molecule, as a potential treatment for fibrotic diseases using a precision-medicine approach. For further information, please visit www.angion.com.
Cherilyn Cecchini, M.D.
LifeSci Public Communications