Angion Biomedica and Vifor Pharma report topline results from phase III trial of ANG 3777 in kidney transplant patients at risk of delayed graft function.
ANG 3777 showed a modest but not statistically significant difference in eGFR of 53.3 mL/min/1.73 m2 versus 50.4 mL/min/1.73 m2 for placebo (2.9 mL/min/1.73 m2, 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 57.1 mL/min/1.73 m2 versus 52.2 mL/min/1.73 m2 (4.9 mL/min/1.73 m2, 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.
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