Everest Medicines Presents Positive Results from Phase 1b/2a Clinical Trial of EVER001 for Primary Membranous Nephropathy at ERA 2025
HONG KONG, Jun 9, 2025 - (ACN Newswire via SeaPRwire.com) - At the 62nd European Renal Association Congress (ERA 2025), Everest Medicines unveiled new clinical data on EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, in patients with primary membranous nephropathy (pMN). This marks the first time EVER001’s clinical data have been unveiled at an international academic congress. This initial unveiling of the preliminary data at an international congress focuses on pMN. The results showed encouraging signals in terms of novel mechanism, preliminary efficacy, and safety. These findings provide a solid foundation for future therapeutic strategies in proteinuric autoimmune glomerular diseases including pMN and demonstrate Everest’s advancing innovation capabilities and global development momentum.EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of primary membranous nephropathy (pMN) and other autoimmune renal diseases, including IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN). These conditions affect over 10 million patients worldwide. There are approximately 2 million pMN patients in China alone and nearly 220,000 across the United States, Europe, and Japan. There are currently no approved therapies globally, and existing treatments rely heavily on non-specific immunosuppressants, which have limited efficacy and safety concerns, highlighting the urgent need for novel mechanism-based therapies.Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. As a covalent reversible BTK inhibitor, EVER001 combines high target-binding affinity with enhanced selectivity, helping to reduce off-target toxicity seen in earlier-generation BTK inhibitors. Its favorable safety and efficacy profile supports its potential to become a new standard of care across proteinuric glomerular diseases.At ERA 2025, preliminary data from the ongoing Phase 1b/2a trial showed that EVER001 was well tolerated and demonstrated promising efficacy in patients with primary membranous nephropathy (pMN). The study enrolled 31 biopsy-confirmed pMN patients who were positive for anti-PLA2R autoantibodies and received either low or high doses of EVER001 over a 36-week treatment period, with extended follow-up for someparticipants. By week 12, anti-PLA2R autoantibody levels dropped by 62.1% in the low-dose group and 87.3% in the high-dose group. Both cohorts saw reductions of approximately 93% by week 24, with 76.9% and 81.8% of patients, respectively, achieving immunologic complete remission. For 24-hour proteinuria, the low-dose group achieved a 78.0% reduction at week 36, sustained through week 52, with 69.2% reaching clinical remission. In the high-dose group, proteinuria declined by 70.1% at week 24, with 80.0% of patients achieving clinical remission.EVER001 was generally well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors—such as bleeding, arrhythmia, severe infections, or liver dysfunction—were observed. Most treatment-related adverse events were mild to moderate (Grade 1–2), further supporting its long-term therapeutic potential.EVER001 is expected to generate strong portfolio synergies with Everest’s commercial-stage product, NEFECON®, the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe. NEFECON® was added to China’s National Reimbursement Drug List (NRDL) in November 2024, and 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, establishing its position as a first-line therapy. To further enhance its IgAN strategy, Everest is also developing a diagnostic test for Gd-IgA1, enabling earlier detection, more accurate disease stratification, and treatment monitoring.By integrating diagnostics and therapeutics into a unified care model, Everest is leading the transition from supportive care to precision, disease-modifying treatment for immune-mediated kidney diseases such as IgAN. This holistic strategy aims to improve disease detection and management standards and establish a comprehensive, long-term renal care platform.With EVER001 and NEFECON® advancing in parallel, Everest is driving innovation in nephrology with the goal of setting new global treatment standards. The presentation of EVER001 at ERA 2025 marks a pivotal milestone in its clinical development and demonstrates the international visibility of China-originated innovations. Everest continues to pave the way for globally competitive novel therapies to reach patients around the world. 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