Angion Biomedica Corp. and Vifor Pharma announced the Phase 3 trial of Angion's ANG-3777 did not demonstrate a statistically significant difference from placebo on the primary endpoint (eGFR at 12 months) in the population of deceased donor kidney transplant patients who were at risk for developing delayed graft function (DGF). ANG-3777 showed a modest but not statistically significant difference in eGFR of 53.3mL/min/1.73m2 versus 50.4mL/min/1.73m2 for placebo (2.9 mL/min/1.73m2, p=0.33).

In addition, ANG-3777 demonstrated an inconsistent benefit on key secondary endpoints. Based upon these data, it is not expected there is sufficient evidence to support an indication in the studied DGF population. The statistical analysis plan also included an analysis of only those people who completed the trial, without using a multiple imputation method to account for missing data and intercurrent events.

Under this analysis, ANG-3777 showed a difference on 12-month eGFR of 57.1mL/min/1.73m2 versus 52.2mL/min/1.73m2 (4.9mL/min/1.73m2, p=0.06) for placebo. These data are potentially indicative of biologic activity of ANG-3777. The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and consistent with the published literature in this patient population.

This multi-center, double-blinded, and placebo-controlled Phase 3 trial randomized 253 patients 1:1 to receive ANG-3777 or a placebo treatment dosed once per day for three days. Eligible patients received a deceased donor transplant and were determined to be at risk for delayed graft function by having low urine output (oliguria) for more than 8 consecutive hours post-transplant, reflecting potential graft injury. Twenty-five transplant centers in the U.S. enrolled patients in this Phase 3 registration trial.

The primary endpoint was renal function assessed by estimated glomerular filtration rate (eGFR) with a primary analysis time point of eGFR at twelve months using a pre-specified multiple imputation method. Angion expects to report cash and cash equivalents as of September 30, 2021 totaling approximately $100 million, when it reports quarterly earnings in November 2021.