Everest Medicines has revealed positive results in the ongoing Phase Ib/IIa clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011). 

In an analysis of the data, results from the trial showed that for patients in the low-dose cohort who have completed 36 weeks of treatment, nine out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission (ICR).  

In the high dose cohort, six out of seven (85.7%) patients achieved overall clinical remission, and all patients achieved ICR by week 24. 

EVER001 is a covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of autoimmune renal diseases.  

Compared to covalent irreversible BTK inhibitors, Everest says EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. 

Based on the patient data collected from the trial, in the low-dose cohort, the geometric least squares mean 24-hour proteinuria decreased by 78.3% at week 36 compared to baseline, while the high-dose cohort achieved a 73.8% reduction by week 24.  

EVER001 treatment induced greater than 90% reductions in anti-PLA2R antibody as early as week 24 in the low-dose cohort and week 12 in the high-dose cohort. 

No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. 

“We are excited to see the encouraging results in this preliminary analysis of our Phase Ib/IIa clinical proof-of-concept trial of EVER001. This demonstrates the potential of EVER001 as a next-generation BTK inhibitor for the treatment of various autoimmune renal diseases, including pMN,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.

Diana Spencer, Senior Digital Content Editor, DDW