Angion's ANG-3777 Faces Third Failure In 2021, This Time Flunks Acute Kidney Injury Trial

Angion Biomedica Corp ANGN and Vifor Pharma shared results from the Phase 2 GUARD trial of Angion's ANG-3777 in cardiac surgery patients with 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 measured between 24 hours after the end of surgery through day 6.
• There was no significant difference in the short-term endpoint between ANG-3777 and placebo (8.4% vs. 7.3%, p=0.77)
• The secondary endpoint of MAKE90 indicated a potential benefit, with fewer patients in the ANG-3777 arm having a MAKE90 event compared to those in the placebo arm.
• MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or over 25% decline in Estimated Glomerular Filtration Rate (eGFR) present 90 days after the surgery. 
• Angion and Vifor Pharma will continue to review the data based on the signal demonstrated in the clinically relevant MAKE90 secondary endpoint.
• Other secondary endpoints did not show a clinical benefit, including endpoints on MAKE30, the incidence of AKI through Day 6.
• The companies already suffered a setback when ANG-3777 failed to beat placebo to improve eGFR, a measure of kidney function.
• Related: Angion Stock Falls As Lead Product Candidate Flunks In COVID-19 Trial.
• Price Action: ANGN shares fell 18.9% at $3.49 during after-hours trading on Wednesday.