Calliditas Therapeutics has reported that its Phase III NefIgArd trial of Nefecon (TARPEYO/Kinpeygo (budesonide) delayed-release capsules) in IgA Nephropathy (IgAN) successfully met its primary endpoint.
The company reported positive topline data from the ongoing international, randomised, double-blind, placebo-controlled trial that investigated Nefecon’s effect versus a placebo in patients with primary IgAN.
It has been designed to evaluate the efficacy and safety of Tarpeyo 16mg once a day, compared to a placebo, in adult primary IgAN patients.
In the trial, Nefecon demonstrated a highly statistically significant benefit compared to a placebo in estimated glomerular filtration rate (eGFR) over a two-year period, comprising nine months of treating subjects with Nefecon or a placebo, and 15 months of follow-up off-drug.
Supportive two-year total slope analyses were found to be statistically significant and clinically meaningful, as well as reflected a sustained treatment benefit.
Calliditas Therapeutics CEO Renée Aguiar-Lucander said: “This is truly a great outcome for IgAN patients.
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“This reflects the 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.”
The data readout obtained from Part B provides longer-term data from the NefIgArd trial that released topline results from Part A in November 2020.
In the third quarter of this year, an additional 29 Chinese patients are expected to complete Part B, as required for local Chinese regulatory purposes.
The analysis for the NefIgArd trial included 364 subjects with primary IgAN and who has a background of optimised and stable renin-angiotensin system (RAS) inhibitor therapy.
They were randomised in a 1:1 ratio into one of two treatment groups.
Nefecon was found to be generally well-tolerated and the safety profile was consistent with that observed in the trial’s Part A.