CALT - Calliditas' Nefecon successful in late-stage study in kidney disease

Calliditas Therapeutics (CALT) announces positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, investigating the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN). The analysis included 199 patients. The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months.The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo.The study also achieved the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of Nefecon compared to placebo.eGFR, showed a treatment benefit of 7% versus placebo, reflecting

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Calliditas' Nefecon successful in late-stage study in kidney disease