Calliditas Announces Positive NefIgArd Open Label Extension Results

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon in the NefIgArd study.

NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day of Nefecon or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug. The NefIgArd study achieved both its primary and key secondary endpoints and was the basis for full approval by the FDA in December 2023. The full data set was published in The Lancet.

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