Calliditas Therapeutics has announced results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy.
The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo 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.
“This is truly a great outcome for IgAN patients. This reflects sustained impact on kidney function across the entire study population with a treatment which was specifically designed to treat IgAN by downregulating pathogenic IgA1 antibodies at their presumed source and we believe this dataset supports regulatory filing for full approval based on the Phase 3 study population,” says CEO Renée Aguiar-Lucander.
Calliditas plans to file for full approval from the FDA
“I am delighted with the positive outcome of the NefIgArd trial. This important milestone is the culmination of many years of hard work and dedication from so many people involved in the study. I would like to extend my thanks in particular to the investigators and site staff involved in the study, as well as of course the participating patients,” said Calliditas’ CMO, Dr. Richard Philipson.
On the basis of this data, Calliditas plans to file for full approval from the FDA, and support filing for full approval with EC and UK MHRA during 2023 for patients with primary IgAN based on the Phase 3 study population.
Photo of Renée Aguiar-Lucander: Calliditas