Calliditas Therapeutics’ NefIgArd phase 3 trial results published in The Lancet

Everest Medicines partner Calliditas Therapeutics AB announced the publication in The Lancet of the full data from the NeflgArd Phase 3 trial with Nefecon in adults with primary IgA nephropathy. The Phase 3 trial met its primary endpoint, estimated glomerular filtration rate, with Nefecon demonstrating significant kidney protective effect over placebo. The analysis published in The Lancet 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(R) 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(R) 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. The reduction in UPCR observed with Nefecon(R) treatment was durable, reflecting a long-lasting treatment effect during the 15-month follow-up period off treatment. Patients treated with Nefecon(R) 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(R) was generally well tolerated, with the majority of treatment-emergent adverse events being mild or moderate, and with TEAEs leading to discontinuation of study drug in less than10% of patients. Objective measures of mean weight and blood pressure showed non-clinically relevant changes. Nefecon(R) has been approved and marketed in the United States under the brand name TARPEYO(R), and under the brand name Kinpeygo(R) in the European Union and the UK under accelerated and conditional approval, respectively.