Everest Medicines Presents Positive Results in Preliminary Analysis of Phase 1b/2a Clinical Trial of Novel BTK Inhibitor EVER001 at the 62nd Congress of the European Renal Association
- 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), offering treatment options for over 10 million patients worldwide.
- No drug has been approved globally for the treatment of pMN currently. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan.
- As of December 17th, 2024, the ongoing Phase 1b/2a clinical trial of EVER001 includes longer-term data collected from some patients: 10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment.
- Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases.
- Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24.
- In the low-dose cohort, a 78.0% of reduction in proteinuria was observed by the end of 36 weeks of treatment. This reduction was sustained through week 52. In the high-dose cohort, a 70.1% of reduction in proteinuria at week 24 was shown.
- EVER001 was generally safe and well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors were observed.
SHANGHAI, June 9, 2025 /PRNewswire/ -- 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 positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor will be presented in a focused oral session at the 62nd Congress of the European Renal Association (ERA 2025).
Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases. This initial unveiling of the preliminary data at an international congress focuses on pMN, which is the second most common cause of primary glomerulonephritis.
EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases.
This oral presentation highlights an ongoing Phase 1b/2a clinical trial of EVER001 for the treatment of pMN, which is being conducted in China. The study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. A total of 31 patients with biopsy-proven pMN who tested positive for anti-PLA2R autoantibodies were enrolled into two cohorts. The total treatment duration was 36 weeks.
The presentation includes longer-term data collected from some patients (10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment). Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases.
The trial results, based on data analysis as of December 17th, 2024, demonstrated that EVER001 was generally safe and well tolerated, with the most common TRAEs being Grade 1-2. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors, such as bleeding, arrhythmia, severe infections, or severe liver function impairment were observed.
Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24. 76.9% of patients in the low-dose cohort and 81.8% in the high-dose cohort achieved immunological complete remission at week 24. For 24-hour proteinuria, the LS geometric mean decreased by 78.0% from baseline in the low-dose cohort at week 36 and the reduction was maintained for 16 weeks after the end of treatment. At week 36, 69.2% of patients in the low-dose group achieved clinical remission. In the high-dose cohort, proteinuria had already decreased by 70.1% at week 24, with 80.0% of patients achieving clinical remission. Patients in both cohorts maintained stable renal function during the treatment period.
"As a next-generation BTK inhibitor, EVER001 offers key advantages, including covalent reversibility, high selectivity, strong target-binding affinity, and reduced off-target toxicity. These attributes highlight its substantial potential in the treatment of pMN." Professor Minghui Zhao, leading principal investigator of EVER001 and an influential nephrologist at Peking University First Hospital, said: "Preliminary results from the Phase 1b/2a clinical trial of EVER001, presented at the 62nd ERA Congress, demonstrate that EVER001 induced rapid reductions in anti-PLA2R autoantibodies and proteinuria observed across both low- dose and high-dose cohorts. The treatment exhibits a favorable safety and tolerability profile. Currently, no drug has been approved globally for the treatment of pMN. Traditional immunosuppressive therapies carry a high risk of relapse following discontinuation, and many are associated with adverse effects. We therefore hope that new treatment options will become available to offer patients safer and more effective therapies."
"To date, no drug has been approved globally for the treatment of pMN. As a potential best-in-class therapy, EVER001 holds promise to offer more treatment options for over 10 million patients worldwide affected by pMN, IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN)." Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said: "We are very pleased to see that the positive results in the preliminary analysis of our Phase 1b/2a clinical proof-of-concept trial of EVER001 were presented for the first time at an international academic conference. These preliminary results, disclosed at the 62nd ERA Congress, demonstrated that this next-generation covalent reversible BTK inhibitor was well-tolerated and effective in patients with pMN. Moving forward, we will continue to drive the global clinical development of EVER001, to meet patients' urgent clinical needs."
pMN is a common pathological type of nephrotic syndrome in adults, and its prevalence in China has been increasing, ranking second only to IgA nephropathy[1]. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan. There are no approved drugs for this indication worldwide. The current treatment goal is to improve remission rates, reduce high relapse rates, and minimize the risk of chronic toxicity caused by currently available treatments. More than one-third of pMN patients still progress to end-stage renal disease under current standards of care.
This Phase 1b/2a clinical trial was approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022 to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria.
About EVER001
EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases.
Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases.
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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References:
1. Expert consensus on the application of rituximab in the treatment of membranous nephropathy, Chin J Intern Med, March 2022, Vol. 61, No. 3.
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