Everest Medicines Announces Positive Results of Complete Chinese Subpopulation Data from the NEFECON® Global Phase 3 NefIgArd Clinical Trial Published in "Kidney 360" Magazine
Tuesday, 22 October 2024
Shanghai, China – October 22, 2024 – Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the "Kidney 360" magazine has published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON^® under the title "Efficacy and Safety of Nefecon in Patients With Immunoglobulin A Nephropathy From Mainland China: 2-Year NefIgArd Trial Results".
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
|
||||
|
|
||||
You Might Like |
||||
