Biopharmaceutical firm Angion Biomedica has received approval from the US Food and Drug Administration (FDA) to start the Phase II GUard Against Renal Damage (GUARD) trial of investigational drug BB3 in patients with acute kidney injury (AKI).
Discovered by Angion, BB3 is a proprietary small molecule that mimics the activity of hepatocyte growth factor (HGF).
According to the firm, the investigational drug showed organ protective and regenerative therapeutic effects in preclinical models of AKI.
Angion Biomedica president and CEO Dr Itzhak Goldberg said: “We are pleased to receive FDA clearance to evaluate BB3 in patients at high risk for acute kidney injury.
“The GUARD study complements our Phase III study on BB3 in renal transplant patients presenting with delayed graft function, another form of AKI.”
The company has designed the trial to assess the potential of BB3 to treat AKI in patients who undergo open heart surgery and require the use of cardiopulmonary bypass.
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GUARD is a multicentre, randomised, placebo-controlled and double-blind trial that will enrol around 100 patients in the US.
Angion said that the study will include patients that have risk factors for AKI, including existing kidney disease, previous cardiac surgery, compromised heart function, advanced age, and diabetes.
University of Maryland School of Medicine nephrology division head and medicine professor Dr Matthew Weir said: “The evaluation of BB3 to treat patients at risk for AKI, and Angion’s additional Phase III clinical trial of BB3 to treat delayed graft function in renal transplant patients, are both very exciting.”