Calliditas Therapeutics has reported that the Phase III NefIgArd study of Nefecon for the treatment of primary IgA nephropathy (IgAN) in adults has met its primary endpoint.
The study compared the effect of Nefecon/TARPEYO (budesonide) delayed release capsules/Kinpeygo) against a placebo in patients with primary IgAN.
The patients were assessed over the two-year period of nine-months of treatment with Nefecon and 15 months of follow-up off-drug.
The analysis published in the Lancet showed a highly statistically significant and clinically relevant benefit in estimated glomerular filtration rate (eGFR) in the treatment group, compared with a placebo.
Nefecon was found to be generally well tolerated, with mild or moderate treatment-emergent adverse events (TEAE) observed during the study.
It also demonstrated significant kidney protective effect over a placebo.
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Less than 10% of patients discontinued the study due to TEAEs. Non-clinically relevant changes were seen in objective measurements of mean weight and blood pressure.
Calliditas CEO Renée Aguiar-Lucander said: “The established long-term eGFR benefit reflects Nefecon’s ability to slow kidney function decline by targeting the origin of the disease and providing a differentiated and disease-modifying treatment alternative.”
University of Leicester Renal Medicine mayer professor Jonathan M Barratt said: “IgAN is a severe, debilitating disease leading to end-stage kidney disease in more than 50% of the patients. The full results from NefIgArd study demonstrate the ability of Nefecon to slow kidney function deterioration and as such to slow down the disease progression and delay the need for dialysis and kidney transplantation.
“These results also support the key role of the gut immune system in the pathogenesis of IgAN and the differentiated effect of Nefecon treating the disease at its origin.”
Nefecon is currently approved under accelerated approval to lower proteinuria in adults with primary IgAN with risk of rapid disease progression, generally a UPCR of ≥1.5 g/g.
To obtain full approval from the FDA, the company submitted a supplemental new drug application in June this year, based on the full NefIgArd study data.
The company is also backing its partner Stada Arzneimittel with the filing for full approval with the European Commission and the UK MHRA in the second half of this year.