Calliditas Therapeutics presents Phase 3 NefIgArd study data

Everest Medicines’ partner Calliditas Therapeutics “presented new biomarker and subgroup analyses from Nefecon’s Phase 3 NefIgArd study in both posters and oral presentations at the 17th International Symposium on IgA Nephropathy held in Tokyo, Japan. IgA-containing immune complexes have previously been shown to accumulate in renal tissue, where they trigger inflammation and scarring of the glomeruli. Investigation of the effect of Nefecon on circulating levels of IgA-IC in the Part A population of the NefIgArd clinical trial revealed that patients treated with Nefecon(R) 16mg/day exhibited a statistically significant decrease in IgA-IC levels compared to patients who received placebo when evaluated at the 3-, 6- and 9-months post randomization. Suppression by treatment with Nefecon of both IgA-IC formation and galactose-deficient IgA1 as previously reported offers an unprecedented opportunity to target the fundamental immune abnormalities that drive IgA deposition in the kidney and development of IgAN. An additional analysis of the 160 patients enrolled in Part A of the Phase 3 NefIgArd clinical study was conducted to assess the levels of three soluble factors known for modulating B cell maturation in gut-associated lymphoid tissue: B-cell activating factor, a proliferation-inducing ligand and serum B-cell maturation antigen. Compared to placebo, levels of BAFF were decreased at 3-, 6-, and 9-months after treatment initiation. Levels of APRIL were significantly reduced at the 3- and 6-months timepoints and levels of sBCMA were decreased at the 6-months timepoint. These data further support the potential disease-modifying effect of Nefecon(R) in IgAN and reinforce the central role of the gut-kidney axis in the pathogenesis of IgAN.”