Calliditas Therapeutics has announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon in adults with Primary IgA nephropathy (IgAN).
The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over placebo, states the company in a press release.
“We are thrilled to see the NefIgArd Phase 3 data published in The Lancet, highlighting these important results for the IgAN patient community,” says Renée Aguiar-Lucander, Chief Executive Officer at Calliditas. “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.”
The analysis published shows that Nefecon demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in eGFR over the two-year period of 9-months of treatment with Nefecon and 15-months of follow-up off drug. After the two-year period, there was a 6.11 mL/min/1.73 m2 decline in eGFR in the Nefecon arm compared with a 12.0 mL/min/1.73 m2 decline in the placebo arm, corresponding to a difference in two-year eGFR total slope of 2.95 mL/min/1.73m2 per year (p<0·0001).
The reduction in UPCR observed with Nefecon treatment was durable, reflecting a long-lasting treatment effect during the 15-month follow-up period off treatment. Patients treated with Nefecon maintained a greater than 30% proteinuria reduction from the end of the 9-month treatment through the entire follow-up period, with a reduction in UPCR of over 50% observed at 12 months.
Nefecon was generally well tolerated, with the majority of treatment-emergent adverse events (TEAE) being mild or moderate, and with TEAEs leading to discontinuation of study drug in <10% of patients. Objective measures of mean weight and blood pressure showed non-clinically relevant changes.
Nefecon is currently approved under accelerated approval to reduce proteinuria in adults with Primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 g/g. In June 2023, Calliditas submitted a supplemental new drug application (sNDA) to the United States Federal Drug Administration (FDA) seeking full approval based on the full NefIgArd study data. Calliditas is supporting its partner STADA Arzneimittel AG with the filing for full approval with the European Commission and the UK MHRA in 2H of 2023.
Photo of Renee-Aguiar-Lucander: Calliditas