Calliditas Therapeutics AB (Calliditas) announced positive topline results from the global, randomized, double-blind, placebo-controlled phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (Tarpeyo/Kinpeygo (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).
The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug.
Supportive 2-year total slope analyses were statistically significant and clinically meaningful reflecting a sustained treatment benefit.
The eGFR benefit was observed across the entire study population, irrespective of urine protein-to-creatinine ratio (UPCR) baseline, which the company believes supports a regulatory filing for full approval in the study population.
UPCR reductions observed were durable, reflecting a long lasting treatment effect during the 15-month follow-up period off treatment.
