The study concerns the use of Nefecon among adult patients with primary IgA nephropathy
Calliditas Therapeutics has announced publication of its NefIgArd trial in The Lancet. The phase 3 study concerns the use of Nefecon among adult patients with primary IgA nephropathy (IgAN).
The clinical trial met the primary endpoint – estimated glomerular filtration rate (eGFR) – with Nefecon duly showing a considerable kidney protective impact versus the placebo.
The analysis also demonstrated that Nefecon has a clinically relevant and statistically significant benefit compared to placebo, in eGFR, over nine-months of using Nefecon and 15-months of follow-up treatment.
The decrease in urine protein/creatinine ratio (UPCR) observed with Nefecon treatment was resilient, indicating a long-lasting treatment effect during the 15-month follow-up treatment period.
Patients treated with Nefecon sustained a greater than 30% proteinuria reduction from the end of the nine-month treatment and throughout the duration of the follow-up period, with a reduction in UPCR of over 50% observed at one year.
Ultimately, Nefecon was well tolerated, with the majority of adverse events either mild or moderate, while objective measures of mean weight and blood pressure showed non-clinically relevant changes.
Renée Aguiar-Lucander, Chief Executive Officer at Calliditas, reflected: “We are thrilled to see the NefIgArd Phase 3 data published in The Lancet, highlighting these important results for the IgAN patient community.”
She added: “The established long-term eGFR benefit reflects Nefecon’s ability to slow kidney function decline by targeting the origin of the disease and providing a differentiated and disease-modifying treatment alternative.”
Jonathan M. Barratt, Mayer Professor of Renal Medicine at the University of Leicester, concluded: “IgAN is a severe debilitating disease leading to end-stage kidney disease in more than 50% of the patients. The full results from NefIgArd study demonstrate the ability of Nefecon to slow kidney function deterioration and as such to slow down the disease progression and delay the need for dialysis and kidney transplantation.
“These results also support the key role of the gut immune system in the pathogenesis of IgAN and the differentiated effect of Nefecon treating the disease at its origin.”
