Everest : China Approves IND Application For Phase 1b Study Of EVER001 In Glomerular Diseases

Everest Medicines said 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, a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, in development for the treatment of glomerular diseases.

The company noted that 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 a 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.

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