Nefecon Shows IgAN Benefits Regardless of Baseline eGFR

TOPLINE: 

Nefecon, an oral targeted-release formulation of budesonide that targets drug release into the distal ileum, provided significant improvements in the loss of kidney function in patients with immunoglobulin A nephropathy (IgAN) at 9 months, regardless of baseline estimated glomerular filtration rate (eGFR) status, according to a new subanalysis of the phase 3 NeflgArd study.

METHODOLOGY:

• Patients in the NeflgArd study with primary IgAN were randomly assigned to one of two groups of 182 patients each to receive either treatment with 16 mg Nefecon or placebo daily, along with supportive care with renin-angiotensin system inhibition. This was followed by a 15-month off-drug observational period allowing for continued supportive care.
• For the subanalysis, the patients were further stratified on the basis of eGFR deciles in relation to the overall study population, with levels above and below 38, 43, 47, 51, 55, 60, 66, 72, and 82 mL/min/1.73 m².
• The median eGFR overall was 55.49 mL/min/1.73 m² and was balanced across the Nefecon and placebo groups.

TAKEAWAY: 

• The relative benefit of Nefecon in terms of eGFR was seen across most deciles and timepoints and showed a generally greater benefit in higher baseline eGFR groups (above 72 mL/min/1.73 m²).
• Furthermore, the relative urine protein-creatinine ratio benefit was observed from month 9 with Nefecon vs placebo regardless of baseline eGFR, with a continued reduction to month 12, followed by a maintained treatment benefit to month 24.
• The eGFR benefits with Nefecon over placebo were observed among patients within the upper and lower deciles over 2 years.
• eGFR showed a pronounced on-treatment benefit and a delay in decline during the observation period.

IN PRACTICE:

“This NefIgArd subanalysis demonstrated that the efficacy of a 9-month Nefecon treatment course in reduction of proteinuria and preservation of kidney function was independent of baseline eGFR,” said first author Jonathan Barratt, MD, of the College of Life Sciences, University of Leicester, UK.

“So, we should be confident about treating people with Nefecon across the full range of eGFR in terms of the eGFR saving we’re going to see, but also the proteinuria reduction,” he added.

SOURCE:

The findings were reported this week at the 62nd European Renal Association (ERA) Congress 2025.

DISCLOSURES:

The study was funded by Calliditas Therapeutics AB.