Everest Medicines’ Partner Calliditas Therapeutics Announces Full Results From NefIgArd Phase 3 Trial published in The Lancet
Friday, 18 August 2023
Shanghai, China — August 18, 2023 — Everest Medicines’ (HKEX 1952.HK, “Everest”, or the "Company") partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced the publication in The Lancet of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The Phase 3 trial met its primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon® demonstrating significant kidney protective effect over placebo.
“The publication of the NefIgArd Phase 3 trial data in The Lancet highlights the significance of these data, and the efficacy of Nefecon® as a first-in-disease therapy for IgAN patients. 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,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Everest participated in the NefIgArd study, and plans to publish the Chinese subpopulation data in a future medical conference. We look forward to bringing Nefecon® to Chinese patients as we await the review of our New Drug Application in the second half of this year.”
“The data demonstrated supportive 2-year total slope analyses that were not only statistically significant but also clinically meaningful, showcasing a sustained treatment benefit. The eGFR benefit was observed across the entire study population, irrespective of baseline urine protein-to-creatinine ratio (UPCR),” said Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare and lead author of the publication. “The sustained reduction of proteinuria and the protective effect on kidney function support the disease-modifying effect of Nefecon. These robust results provide new hope for patients and reinforce Nefecon’s potential to make a meaningful difference in the lives of those affected by this challenging disease.”
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® and 15-months of follow-up off drug. After the two-year period, there was a 6.11 mL/min/1.73 m^2 decline in eGFR in the Nefecon® arm compared with a 12.0 mL/min/1.73 m^2 decline in the placebo arm, corresponding to a difference in two-year eGFR total slope of 2.95 mL/min/1.73m^2 per year (p
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