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China NMPA approves Everest Medicines IND application for phase 1b study of EVER001, a novel BTK inhibitor to treat renal diseases

Shanghai, China
Tuesday, September 27, 2022, 11:00 Hrs  [IST]

Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that the China National Medical Products Administration (NMPA)’s Center for Drug Evaluation has approved the Investigational New Drug (IND) application for a phase 1b study of EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, in development for the treatment of glomerular diseases.

The planned phase 1b clinical study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of EVER001 in patients in China with glomerular disease characterized by proteinuria, a common cause of chronic kidney disease. Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience in September 2021, Everest owns the global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. Based on a Phase 1 study in healthy subjects in China conducted by SinoMab, EVER001 exhibited high selectivity, excellent pharmacokinetics properties and safety profile as well as robust target engagement.

“The advancement in clinical development of EVER001 for glomerular diseases represents one of the potentially first-in-class therapeutic opportunities that exist across Everest’s broad pipeline and highlights our long-term growth strategy to advance innovative and high-quality therapies for the benefit of patients worldwide with unmet demand,” said Zhengying Zhu, Ph.D., chief medical officer for Internal Medicine at Everest Medicines. “Chronic kidney disease is a leading global public health problem and will remain as a top area of therapeutic focus for Everest Medicines. The initiation of this Phase 1b trial, alongside the pivotal-stage development of Nefecon, our lead asset in renal disease, strengthens the Company’s commitment in this space and we look forward to progressing these important potential therapies as quickly as possible.”  

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 signalling 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.  Based in part on results from a completed phase 1 study with healthy subjects conducted by SinoMab in China, EVER001 exhibited high selectivity, excellent pharmacokinetics properties, robust target engagement and a safety profile that supports continued clinical development.

Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns the global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases.

 

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