Everest Medicines and its partner Calliditas Therapeutics have presented new biomarker and subgroup analyses from the Phase 3 NefIgArd study of Nefecon® at the 17th International Symposium on IgA Nephropathy in Tokyo, Japan.
Nefecon® is being developed for the treatment of IgA nephropathy (IgAN), a kidney disease. The analyses showed that patients treated with Nefecon® exhibited a statistically significant decrease in IgA-containing immune complexes (IgA-IC) levels, as well as suppression of key factors known to modulate B cell maturation in gut-associated lymphoid tissue.
These findings support the potential disease-modifying effect of Nefecon® in IgAN and highlight its role in targeting the gut–kidney axis in the pathogenesis of the disease. Nefecon® has already been approved in the United States, the European Union, and the UK, and its approval in mainland China is expected in the second half of this year.
Nefecon® is a patented oral formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. This formulation is designed as a delayed-release capsule that is enteric-coated to remain intact until it reaches the Peyer’s patch region of the lower small intestine. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, where the disease originates in the context of IgA nephropathy (IgAN).
Everest Medicines entered into an exclusive license agreement with Calliditas in June 2019, granting Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was later extended in March 2022 to include South Korea as part of Everest Medicine’s territories for Nefecon® development and commercialization.
Nefecon® has shown promise in the treatment of IgAN, and these agreements aim to bring this innovative therapy to patients in these regions where there is a need for effective treatments for the disease.
About Everest Medicines
Everest Medicines is a biopharmaceutical company with a primary focus on developing, manufacturing, and commercializing innovative pharmaceutical products and vaccines to address significant unmet medical needs in Asian markets.
The company is guided by a management team with extensive expertise and a strong track record gained from leading global pharmaceutical companies as well as local Chinese pharmaceutical firms. Their expertise spans various areas, including drug discovery, clinical development, regulatory affairs, chemistry, manufacturing, and controls (CMC), business development, and operations.
Everest Medicines has curated a portfolio of promising molecules, many of which have the potential to be global first-in-class or best-in-class therapies. These molecules are typically in advanced stages of clinical development. The company’s therapeutic focus encompasses renal diseases, infectious diseases, and autoimmune disorders.
The aim of Everest Medicines is to bring innovative treatments and vaccines to patients in Asia who are facing significant medical challenges. By addressing unmet medical needs, particularly in these key therapeutic areas, the company strives to make a positive impact on healthcare outcomes in the region.