Angion Biomedica Corp.'s Phase 2 “GUARD” Clinical Trial Of BB3 In Acute Kidney Injury (AKI) Underway; Complements Ongoing Phase 3 Study In Renal Transplant Recipients With Delayed Graft Function (DGF)
UNIONDALE, N.Y.--(BUSINESS WIRE)--Angion Biomedica Corp. announced today that its Phase 2 “GUARD” clinical trial (GUard Against Renal Damage) using investigational drug BB3 in patients at risk for acute kidney injury (AKI) was underway with the first patient being dosed. BB3 is also being evaluated in an ongoing Phase 3 clinical study in DGF patients. BB3 has demonstrated therapeutic effects in preclinical models of AKI and therapeutic activity in a Phase 2 DGF study in renal transplant recipients.
“The GUARD study complements our Phase 3 “GIFT”
“We are very pleased to announce that the first subject was enrolled in the BB3 GUARD study,” said Itzhak D. Goldberg, MD, FACR, President and CEO of Angion. “The GUARD study complements our Phase 3 “GIFT” study of BB3 in renal transplant patients presenting with delayed graft function, another form of AKI. Our recently completed Phase 2 study using BB3 in renal transplant DGF patients showed activity of the drug by several different measures of renal damage, including biomarkers of renal function and injury. We are excited to be extending our clinical programs, supported by numerous preclinical studies, into both types of acute kidney injury - a complication of heart surgery and a complication in renal transplantation.”
AKI is one of the most serious and frequent in-hospital complications and is associated with increased mortality, need for dialysis, extended hospital stay, increased risk of infection, increased incidence of chronic kidney disease, and concomitantly, increased costs to health systems. There is currently no FDA-approved drug therapy for the prevention or treatment of AKI. Patients who undergo cardiac surgery involving use of cardiopulmonary bypass, also known as a heart-lung machine, in combination with predisposing factors, are at increased risk for AKI. The GUARD study is designed to evaluate the potential of BB3 to treat AKI in patients who undergo open heart surgery and require the use of cardiopulmonary bypass. GUARD is a multicenter, randomized, placebo-controlled, double-blind study involving approximately 100 patients in the U.S. that have risk factors for AKI including existing kidney disease, previous cardiac surgery, compromised heart function, advanced age, and diabetes.
"I am delighted that Angion Biomedica has commenced patient enrollment for their BB3 AKI Phase 2 Guard trial. Successful completion of this trial and Angion's DGF Phase 3 GIFT trial would have a major impact on multitudes of patients worldwide for which currently there are no available treatments" said Matthew R. Weir, M.D., Professor of Medicine and Head of the Division of Nephrology at the University of Maryland School of Medicine.
About Angion Biomedica Corp.
Angion Biomedica Corp. is a biopharmaceutical company established in 1998 to discover and develop novel therapeutic agents to treat patients who experience acute and chronic organ disorders and diseases. Our programs are currently focused on renal transplantation, acute kidney injury and chronic kidney disease. Angion retains worldwide rights to BB3. For further information, please visit www.angion.com, or contact us at email@example.com.
Angion Biomedica Corp.
Joanne Bazilio-Johnson, 516-326-1200 ext. 200