Positive NefIgArd open label extension results for Calliditas

Swedish biopharma Calliditas Therapeutics (Nasdaq: CALT) today announced positive global open-label extension (OLE) Phase III NefIgArd study results in IgA nephropathy (IgAN) patients treated with Nefecon/Tarpeyo (budesonide).

NefIgArd was a global, Phase III, 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 16mg/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 US Food and Drug Administration (FDA) in December 2023.

The OLE study was designed to provide nine months of treatment with Nefecon for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and > 30 ml/min of eGFR. All enrolled OLE patients continued on optimized RAS inhibitor therapy (ACEs and/or ARBs) and were treated for nine months with Nefecon 16mg per day, with a follow-up visit three months after completion of treatment.