Clinical Data Topline Results
The analysis included 199 patients diagnosed with primary IgA Nephropathy and who were on a background of optimised and stable renin-angiotensin system, or RAS inhibitor therapy. The patients were randomised in a 1:1 ratio into one of two treatment groups – Nefecon 16 mg/day or placebo – and treated orally for 9 months daily.
24-hour UPCR (proteinuria) Data
The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo.  
eGFR Data
The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilisation in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group.  Safety Profile
The results indicate that Nefecon was generally well-tolerated and were consistent with the known safety profile of Budesonide. The number of withdrawals in the trial was significantly less than what was seen in the Phase 2b NEFIGAN trial.“I would like to thank all of the investigators, site staff and of course patients for their commitment and dedication to this important trial. I look forward to continuing this excellent work through completion of Part B of the trial,” said Calliditas CMO, Dr. Richard Philipson.
The NefIgArd trial is continuing on a blinded basis with patients continuing in the observational Part B of the trial for a 12 month follow up period post their completion of Part A. Calliditas is recruiting an additional 160 patients for inclusion in Part B during 2020 and aims to complete the recruitment in Q4 2020 or Q1 2021, depending on the impact of COVID-19.