Everest Medicines
News Detail
Press Release News vom 08.09.2020
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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—September 8, 2020 — 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).
“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,” said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines. “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 Nefecon’s global late-stage development.” About Nefecon Nefecon, 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 Peyer’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. About IgA Nephropathy IgA Nephropathy(IgAN) a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com. For further information, please contact: Everest Medicines |
