The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the same outcomes in the global trial. Compared with the placebo, NEFECON® treated patients showed greater preservation of estimated glomerular filtration rate (eGFR) within 9 months and over 2 years, and the treatment benefits observed in Chinese patients were numerically larger, with good tolerability and no new safety signals observed. Previously, the Chinese subpopulation data were published at the American Society of Nephrology (ASN) Kidney Week held in November 2023.
"The publication of the Chinese subpopulation data from the NEFECON® global Phase 3 NefIgArd clinical trial in the 'Kidney 360' magazine further supports the clinical evidence of NEFECON® in the clinical application for Chinese IgA nephropathy (IgAN) patients. Compared with the European and American populations, the disease progression in the Chinese population with IgAN is faster, and the prognosis is poorer, bringing a heavy disease burden to patients and society.” Said Professor Zhang Hong with Peking University First Hospital, a member of the global steering committee for the Phase 3 clinical trial NefIgArd, chairman of the Chinese Collaborative Group of the International IgA Nephropathy Federation. “The data analysis of the Chinese subpopulation in the NefIgArd trial shows a clear benefit of treatment with NEFECON® in Chinese patients. After a 9-month treatment period with NEFECON® and 15 months of follow-up off drug, significant kidney function protection was achieved within 2 years, reducing the decline in kidney function by 66% over 2 years, and a continuous decrease in proteinuria was observed. At 9 months, the urine protein to creatinine ratio (UPCR) significantly decreased by 37.6% from the baseline, and the decline was well maintained during the 15-month follow-up period off drug, with numerical benefits superior to global patients. Currently, there are many IgAN patients in China, and we look forward to more Chinese patients starting etiological treatment earlier in the future."
"The recently published Chinese subpopulation data from the global Phase 3 NefIgArd clinical trial for NEFECON® in Kidney 360 further validates the significant clinical benefits NEFECON® offers to Chinese patients, solidifying its position as the first-line cornerstone treatment for IgAN.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “With IgAN incidence rates notably higher in Asia compared to other regions, and its high prevalence in the Asian population – where there is a 56% higher risk of progression to end-stage renal disease and faster disease progression, there is a clear indication of significant unmet clinical needs. As the world's first etiological treatment for IgAN, NEFECON® directly addresses the cause of the disease, filling a crucial gap in treatment. Moving forward, we are committed to enhancing NEFECON®'s accessibility and advancing its commercialization across Asia to benefit more patients as soon as possible.”
The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy. Patients were randomly assigned in a 1:1 ratio to receive NEFECON® or matched placebo for 9 months, followed by a 15-month off drug follow-up period. The NEFECON® global Phase 3 NefIgArd clinical trial achieved its primary and key secondary endpoints, and the complete data have been published in The Lancet magazine. The FDA fully approved NEFECON® for the treatment of adult patients with IgAN at risk of progression in December 2023 based on the results of this study, irrespective of proteinuria levels.
Currently, NEFECON® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong, China, Singapore and Taiwan, China. In July this year, the National Medical Products Administration officially accepted the supplementary application for the complete data of the final clinical trial stage of NEFECON®, and NEFECON® is expected to become the first and only fully approved etiological treatment for IgAN in China. In addition, NEFECON® was recently included in the latest draft for public review, "KDIGO 2024 Clinical Practice Guideline for The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) " and was listed in the guideline draft as the only treatment proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes.
About Phase 3 NefIgArd Clinical Trial
The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy. This study lasted for 2 years, including a 9-month treatment period with NEFECON® or placebo, followed by a 15-month off drug follow-up period. The global study results showed that compared with the placebo, NEFECON® not only brought a lasting decrease in proteinuria and reduced the risk of microscopic hematuria, but more importantly, it showed a clinically significant and statistically significant advantage (p<0.0001) in estimated glomerular filtration rate (eGFR), delaying the decline of kidney function by 50%.
The Chinese subpopulation data showed better efficacy in kidney function protection, proteinuria reduction, and improvement of microscopic hematuria compared to the global study in numerical values, and a faster disease progression was also observed in the Chinese patient control group using only supportive treatment. During the 2-year treatment and observation period, the time-weighted average decline in eGFR in the NEFECON® treatment group was 3.7 ml/min/1.73m2, while the time-weighted average decline in eGFR in the placebo group was 13.3 ml/min/1.73m2. NEFECON® treatment could bring a benefit of 9.6 ml/min/1.73m2 in eGFR, a value greater than the treatment benefit in the global population (5.1 ml/min/1.73m2). The average absolute change in eGFR at 24 months compared to the baseline in the Chinese population indicated that the degree of kidney function deterioration in patients treated with NEFECON® was reduced by about 66% compared to the placebo, a value of about 50% in the global population. Additionally, a sustained reduction in proteinuria was observed in the NEFECON® group over the course of two years. Compared with the placebo, the 9-month NEFECON® treatment in the Chinese population reduced the urine protein creatinine ratio (UPCR) by 31% and 43% at 9 months and 24 months, respectively, while the global population decreased by about 30% at 9 months and 24 months. In addition, in the placebo group, the average UPCR in the Chinese subpopulation increased by 18.6% from the baseline at 24 months, while the global population had a slight decrease, indicating that the disease progression in the Chinese population is faster than in the global population. In the Chinese population, the proportion of patients without microscopic hematuria in the NEFECON® group significantly improved from 26.9% at baseline to 57.7% within 2 years, while there was no change in the placebo group.
About NEFECON®
NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
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