Calliditas Therapeutics presents on NeflgArd Phase 3 data at ERA-EDTA

The company states: “Everest Medicines announced that its partner Calliditas Therapeutics AB (CALT) made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress, or ERA-EDTA, which was held in Milan, Italy, June 15-18. The presentations showed data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon in patients with IgA nephropathy. The study met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo in estimated glomerular filtration rate over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug. The key primary endpoint, eGFR over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon compared to placebo. At 24 months, eGFR was reduced by 6.11 mL/min/1.73 m2 from baseline in the Nefecon arm compared with 12 mL/min/1.73 m2 reduction in the placebo arm, demonstrating 50% less loss of kidney function. Treatment benefit on eGFR was apparent across baseline urine protein creatinine ratio subgroups. The reduction in UPCR was also durable, with a 30.7% decrease in UPCR in the Nefecon arm even after 15 months off drug compared with only 1% reduction in the placebo arm. Another analysis of the effect of durability of proteinuria reduction showed a 41% reduction in time-averaged UPCR over 12-24 months compared with placebo. For hematuria treatment, the proportion of patients with microhematuria in the Nefecon arm fell to 40.5% from 66.5% baseline while in the placebo arm, it only decreased to 61.2% from 67.8% baseline. The results also indicate that Nefecon was generally well-tolerated and the safety profile was consistent with that observed in Part A of the trial.”