Positive Outcomes in NefIgArd OLE Study Reported by Calliditas

Swedish biopharmaceutical firm Calliditas Therapeutics has reported positive results from a global open-label extension (OLE) study related to its Phase 3 NefIgArd clinical trial. The study, which was an extension of the NefIgArd trial, aimed to assess the continued efficacy and safety of Nefecon, a medication developed by Calliditas for the treatment of primary IgA nephropathy (IgAN), a rare kidney disease.

The original NefIgArd trial was a comprehensive, randomized, double-blind, placebo-controlled study that took place across multiple centers worldwide. It evaluated Nefecon's impact on adult patients with primary IgAN, supplementing optimized RASi therapy. The trial successfully met its primary and secondary endpoints, leading to the FDA's full approval of Nefecon in December 2023. The detailed results were published in the prestigious medical journal, The Lancet.

Building upon the success of the NefIgArd study, the OLE study focused on providing an additional 9 months of Nefecon treatment to patients who completed the initial trial and still exhibited significant proteinuria and eGFR levels. The study maintained the optimized RAS inhibitor therapy and administered Nefecon at a dosage of 16mg daily. A total of 119 patients participated in the OLE study, with 45 having previously received active treatment.

The OLE study's primary assessment metrics were the urine protein to creatinine ratio (UPCR) and the estimated glomerular filtration rate (eGFR), both measured at the 9-month mark. The findings indicated that Nefecon's treatment effects were consistent with the original NefIgArd study across all patients, regardless of their prior treatment status. The safety profile of Nefecon, as observed after 9 months of treatment or re-treatment, aligned with previously reported data.

Renée Aguiar-Lucander, CEO of Calliditas Therapeutics, expressed enthusiasm over the results, highlighting the significance of proteinuria reduction and eGFR stabilization observed in all patients after 9 months. She emphasized that these outcomes support the hypothesis that the effectiveness of Nefecon is not influenced by the number of treatment cycles a patient has undergone. The company is eager to present these findings at the forthcoming ERA EDTA symposium, a leading event in the field of nephrology.

The positive outcomes of the OLE study reinforce the potential of Nefecon as a reliable treatment option for patients with primary IgAN, offering hope for improved management of this chronic condition. Calliditas Therapeutics continues to demonstrate its commitment to advancing novel therapies for rare diseases with significant unmet medical needs.