Vifor Pharma and Angion Biomedica Corp announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.
The GUARD trial was designed as a signal-finding trial with a primary objective determining the feasibility of advancing ANG-3777 into a global phase-III trial based upon activity and safety of ANG-3777 in patients at risk for CSA-AKI, as there are no approved therapies for these patients.
Topline results appear below. P-values noted were not adjusted for multiple comparisons:
• The primary endpoint was percentage increase in serum creatinine based upon AUC as measured between 24 hours after the end of surgery through day 6, and indicated there was no significant difference in this short-term endpoint between ANG‑3777 and placebo (8.4% vs. 7.3%, p=0.77).
• The secondary endpoint of MAKE90, which has historically been acceptable to global regulatory agencies as an approvable endpoint, indicated a potential benefit in patients receiving ANG-3777 with fewer patients in the ANG-3777 arm having a MAKE90 event compared to those in the placebo arm (14.7% vs. 21.5%, adjusted odds ratio of 0.60, p=0.155). MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in Estimated Glomerular Filtration Rate (eGFR) present 90 days after the surgery. The GUARD trial was not powered to demonstrate a statistically significant result on this endpoint.
• The number of patients who experienced a decline in kidney function as measured by a >25% decrease in eGFR at Day 90 was fewer in the group treated with ANG-3777 (5.6% vs. 16.2%, p=0.012). Other secondary endpoints did not show a clinical benefit, including endpoints on MAKE30, the incidence of AKI through Day 6.
The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and comparable to placebo.
“With the results of this trial, we now have a body of data on the efficacy and safety of ANG-3777 in both transplant and surgery-associated kidney injury,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “Together with our partner Angion, we look forward to thoroughly analyze the full data set and to continue exploring the potential of ANG-3777.”
“This is a preliminary data picture from the trial, and we need additional time to analyze the full data set before determining how we might bring ANG-3777 to patients,” stated John Neylan, MD, Angion’s Chief Medical Officer. “I would like to thank the patients, their families, and the investigators and their staff members who participated and worked diligently to make this trial possible.”
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