BRIEF: Everest unveils positive results for kidney drug EVER001 in Phase 1b/2a trial

Everest Medicines (1952.HK) announced on Wednesday that its EVER001, a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor for treatment of primary membranous nephropathy (pMN), showed positive results in its Phase 1b/2a clinical trial.

Among patients in the trial’s low-dose cohort who completed 36 weeks of treatment, nine out of 11, or 81.8%, achieved overall clinical remission, the company said. Ten out of 11, or 91%, achieved immunological complete remission (ICR). In the high dose cohort, six out of seven patients, or 85.7%, achieved overall clinical remission, and all patients achieved ICR by week 24.

Everest holds global rights to EVER001 for the treatment of renal diseases, establishing it as a promising next-generation clinical asset within the company’s expanding renal pipeline. The company says EVER001 offers improved selectivity while maintaining high potency compared with rival products, potentially avoiding many side effects associated with earlier-generation BTK inhibitors. EVER001 demonstrates broad potential across various autoimmune-driven glomerular diseases.

pMN is a common pathological type of nephrotic syndrome in adults and is getting more prevalent in China, which is estimated to have 2 million patients. In Europe, the number of patients is around 80,000, while there are 80,000 to 100,000 in the U.S. Everest believes EVER001 has strong potential in both the China and global markets due to lack of currently approved other drugs in its class.

In line with its dual-engine strategy of licensing third-party products while advancing in-house R&D, Everest Medicines continues to strengthen its leadership in nephrology. The company is gradually expanding its global footprint and believes it has the potential of partnering with other biotechnology companies. The recent $1.15 billion acquisition of Human Immunology Biosciences (HI-Bio) by U.S.-based Biogen is a case in point for partnerships with complementary expertise.

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