Primary endpoint successfully met in phase III NefIgArd trial evaluating Nefeconin IgA nephropathy.- Calliditas Therapeutics AB.

Results : i.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. ii. Supportive 2-year total slope analyses were statistically significant and clinically meaningful reflecting a sustained treatment benefit. iii. 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 III study population,” said CEO Renée Aguiar-Lucander.

These data show the kidney function protection delivered by Nefecon and demonstrate that the approach offers patients a truly disease modifying treatment with sustained reductions in proteinuria over two years and continued eGFR benefit. Importantly Nefecon was well tolerated and together with the proteinuria and eGFR data mean that Nefecon has cemented its place as a key treatment option for patients with IgA nephropathy at risk of progressive kidney function loss,” said Dr Jonathan Barratt, Mayer Professor of Renal Medicine at Leicester University. .

On the basis of the NefIgArd trial 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 III study population.

Nefecon is being marketed by Calliditas in the US under the brand name Tarpeyo, and by STADA Arzneimittel AG in the EEA, Switzerland and the UK under the brand name Kinpeygo.