Angion Biomedica and Swiss partner Vifor Pharma announced that Angion's lead candidate failed to demonstrate a statistically significant difference in a phase 3 trial of kidney transplant patients who were at risk for developing delayed graft function (DGF).
New York-based Angion's product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic — meaning the drug is designed to mimic the biological activity of HGF in activating critical pathways in the body’s natural organ repair process following an acute organ injury. DGF is a common complication after deceased donor kidney transplantation, necessitating dialysis. Angion's recent 253 patient multi-center, double-blinded trial was aimed to better the placebo on the primary endpoint of renal function assessed by estimated glomerular filtration rate (eGFR) — a biomarker for kidney function.
Earlier this year, the company pitted the drug against COVID in a small phase 2 trial conducted in Brazil to evaluate the safety and efficacy of four doses of ANG-3777 in the reduction of severity and progression of acute lung injury in patients with COVID-19 associated pneumonia — but the drug failed.
Now with ANG-3777 failing to meet endpoints in the kidney transplant trial, the partners "do not expect there is sufficient evidence to support an indication in the studied DGF population." However, Vifor will continue to collaborate with Angion on the development of ANG-3777 in cardiac-surgery associated acute kidney injury. An exploratory phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021.