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Everest Medicines Announces First Patient Randomized in a Phase 3 Clinical Study of Nefecon for IgA Nephropathy Patients in China

SHANGHAI, China, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the first patient has been randomized in China into the NefIgArd Phase 3 global registrational study evaluating Nefecon as a treatment for IgA Nephropathy (IgAN).
NefIgArd is a double-blind, randomized, placebo controlled, multi-center Phase 3 global clinical study to evaluate the efficacy and safety of Nefecon in 360 patients with primary IgA nephropathy at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs).A a??IgAN is the most common primary glomerular disease and has much higher prevalence in China than in western countries, with an estimated 2 million people in China living with IgAN. IgAN is a chronic and progressive disease that can cause a significant portion of patients to gradually lose kidney function and results in end-stage kidney failure,a?? said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines. a??With this milestone, we are one step closer to bringing Nefecon, as the potential first novel therapeutic option, to IgAN patients in China, and are also contributing to the acceleration of Nefecona??s global late-stage development.a??About NefeconNefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyera??s patch in the ileum, which is responsible for the production of secretory immunoglobulin A. Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 2b clinical trial conducted by our partner Calliditas Therapeutics AB (Nasdaq: CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore.A 
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