China-based biotech Everest Medicines (HKG: 1952) has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to conduct a Phase Ib clinical study assessing the safety, efficacy, pharmacokinetics, and pharmacodynamics of its EVER001. The drug candidate, a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, will be evaluated in Chinese patients with glomerular diseases.
Drug Overview and Development
EVER001, previously known as XNW1011, is a next-generation covalent reversible BTK inhibitor being developed globally for the treatment of renal diseases. BTK is a critical component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. 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 renal disease treatments.
Clinical Progress and Future Outlook
Based on a Phase 1 study in healthy subjects in China conducted by SinoMab, EVER001 has demonstrated high selectivity and excellent pharmacokinetic properties, as well as robust target engagement. The approval from the CDE to proceed with the Phase Ib study in patients with glomerular diseases marks a significant step forward in the clinical development of this innovative therapy. Everest Medicines is well-positioned to advance EVER001 through its clinical program, aiming to address significant unmet needs in renal disease treatment.-Fineline Info & Tech
