Everest Medicines Announces Positive Phase 1b/2a Clinical Trial Results for EVER001, a Novel BTK Inhibitor for Primary Membranous Nephropathy Treatment.

Everest Medicines presented positive results in a Phase 1b/2a clinical trial for its novel BTK inhibitor EVER001 in patients with primary membranous nephropathy (pMN). EVER001 reduced anti-PLA2R autoantibodies by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12, and sustained proteinuria reductions through week 52. The drug was well-tolerated with no clinically significant adverse events. EVER001 has the potential to treat autoimmune renal diseases, including IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis, affecting over 10 million patients worldwide.

Everest Medicines, a biopharmaceutical company, presented positive results from a Phase 1b/2a clinical trial of its novel Bruton's tyrosine kinase (BTK) inhibitor, EVER001, at the 62nd European Renal Association Congress (ERA 2025). The trial focused on patients with primary membranous nephropathy (pMN), a condition characterized by proteinuria and autoantibody production [1].

The preliminary data showed that EVER001 effectively reduced anti-PLA2R autoantibodies by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. By week 24, reductions in both cohorts reached approximately 93%. Additionally, EVER001 demonstrated sustained proteinuria reductions through week 52. In the low-dose cohort, 69.2% of patients achieved clinical remission, while 80.0% in the high-dose cohort achieved clinical remission by week 24 [2].

The drug was well-tolerated, with no clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors observed. Most treatment-related adverse events were mild to moderate (Grade 1-2), supporting the long-term therapeutic potential of EVER001 [1].

EVER001 has the potential to treat a wide range of autoimmune renal diseases, including IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis, affecting over 10 million patients worldwide. With no approved therapies globally for pMN, the results of this trial represent a significant step forward in the treatment of these conditions [1].

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 Medicines continues to lead the transition from supportive care to precision, disease-modifying treatment for immune-mediated kidney diseases [2].

References:
[1] https://www.tradingview.com/news/reuters.com,2025-06-09:newsml_ACN100114a:0-everest-medicines-presents-positive-results-from-phase-1b-2a-clinical-trial-of-ever001-for-primary-membranous-nephropathy-at-era-2025/
[2] https://www.prnewswire.com/news-releases/everest-medicines-presents-positive-results-in-preliminary-analysis-of-phase-1b2a-clinical-trial-of-novel-btk-inhibitor-ever001-at-the-62nd-congress-of-the-european-renal-association-302476219.html