NEFECON®: New Results at ERA 2025 Demonstrate Treatment Benefit of the 'Treat Early' Strategy

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• Two new studies on NEFECON^® demonstrate its treatment benefit in the "Treat Early" strategy for IgA nephropathy (IgAN), providing robust support for the new disease management strategy: "Treat the Cause, Treat Early, Treat All":

— A subanalysis of the NefIgArd study demonstrates that early treatment can more effectively slow disease progression and reduce irreversible nephron loss.

— A prospective study indicates that early treatment with NEFECON^® in patients diagnosed within 6 months may better control inflammatory responses and delay disease progression.

SHANGHAI, June 6, 2025 /PRNewswire/ -- At the 62^nd European Renal Association Congress (ERA 2025), nine new studies on NEFECON^® were presented, two of which demonstrate its treatment benefit in the "Treat Early" strategy for IgA nephropathy (IgAN), providing robust support for the new disease management strategy of "Treat the Cause, Treat Early, Treat All".

The new results presented at ERA 2025 demonstrate early treatment with NEFECON^® can help protect renal function and slow disease progression, leading to improved disease management and an improved quality of life for patients.

"The new results have validated the significant role of NEFECON^® in the early intervention of IgAN, and have fully demonstrated its key value in the strategy of 'Treat the Cause, Treat Early, Treat All'." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, "These findings further underscore its outstanding clinical advantages as a first-line cornerstone therapy for IgAN. The 'Treat Early' strategy offers more proactive treatment for IgAN patients, helping to control disease progression and better protect renal function. NEFECON^® is the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe, providing patients with new hope and treatment options.

"The new findings provide robust evidence for early targeted intervention. They show that NEFECON^® significantly reduces proteinuria and protect kidney function across all diagnostic timelines, with the greatest improvements in eGFR observed in patients diagnosed within 0.6 years." Professor Ping Fu from West China Hospital of Sichuan University commented, " This demonstrates that early treatment can more effectively slow disease progression and reduce irreversible nephron loss. Additionally, early treatment with NEFECON^® in patients diagnosed within 6 months may better control inflammatory responses and delay disease progression. The Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review) also recommends NEFECON^® as the preferred treatment to reduce Gd-IgA1. These results emphasize the importance of early treatment for IgAN and provide valuable guidance for clinical practice."

The new results provide a strong evidence-based support for NEFECON^®'s variable effects depending on treatment timing and disease duration. In a subanalysis of the NefIgArd study^[1], which assessed the renal benefits of budesonide delayed-release capsules (16 mg/day) across different diagnostic timelines, 364 primary IgAN patients were stratified into quartiles based on time since biopsy-confirmed diagnosis. Results showed that NEFECON^® preserved eGFR and reduced UPCR versus placebo across all quartiles, with the most significant renal protection in recently diagnosed patients. For those diagnosed <0.6 years prior to baseline, NEFECON^® increased eGFR by +6.41, +5.78, and +4.79 mL/min/1.73 m² at 9, 12, and 24 months, respectively, and reduced UPCR by 51.12% at 12 months.

In a prospective study evaluating the impact of budesonide on inflammatory processes in recently diagnosed versus long-standing IgAN patients^[2], eligible Caucasian adults were divided into two groups: recent diagnosis (RD, n=8, ≤6 months) and established diagnosis (OD, n=6, >6 months). The RD group showed a significant increase in CLU levels from 48.38 pg/ml at baseline (T0) to 94.92 pg/ml at 3 months (T3) (p=0.036), while no significant change was observed in the OD group. This suggests that early NEFECON^® treatment may modulate the renal immune microenvironment, triggering protective protein expression (e.g., CLU) to repair damage. Moreover, eGFR in the RD group gradually improved from T0 to T10, indicating better renal preservation with early intervention.

NEFECON^®, as the only in-disease IgAN treatment has been included in the KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines.

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 Medicines' 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.

Forward-Looking Statements:

This press release may contain forward-looking statements based on current expectations, involving risks and uncertainties. Actual results may differ materially due to various factors. The company undertakes no obligation to update these statements unless required by law.

References:

1.     Lafayette R, et al. Abstract#3251-Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: a subanalysis of the NefIgArd study. Presented at ERA 2025.

2.     Keskinis C, et al. Abstract#2093-Targeted-Release Budesonide (TRB) treatment may have different effects on the inflammatory process in IgAN patients with recent and old diagnosis. Presented at ERA 2025.

SOURCE Everest Medicines