Everest Medicines (HKG: 1952), in partnership with Calliditas Therapeutics AB (Nasdaq: CALT), recently presented new biomarker and subgroup analyses for Nefecon, a targeted oral formulation of budesonide currently under clinical development for the treatment of IgA nephropathy (IgAN). The data was showcased during both poster and oral presentations at the 17th International Symposium on IgA Nephropathy held in Tokyo, Japan.
Phase III NefIgArd Study Highlights
The pivotal Phase III NefIgArd study is a randomized, double-blinded, multi-center, placebo-controlled trial designed to evaluate the efficacy of Nefecon compared to placebo in IgAN patients, based on optimized renin-angiotensin system (RAS) inhibitor treatment. Previous results from the study demonstrated that, over a two-year period (including 9 months of treatment followed by 15 months of discontinuation), Nefecon achieved a sustained decrease in proteinuria and reduced the risk of microscopic hematuria by 60%. Additionally, it showed a clinically and statistically significant improvement in estimated glomerular filtration rate (eGFR) (P<0.001), effectively delaying renal function decline by up to 50%.
Biomarker Analysis Reinforces Nefecon’s Efficacy
An additional analysis involving 160 patients enrolled in Part A of the Phase III NefIgArd study focused on three soluble factors that modulate B cell maturation in gut-associated lymphoid tissue (GALT): B-cell activating factor (BAFF), a proliferation-inducing ligand (APRIL), and serum B-cell maturation antigen (sBCMA). Results indicated that, compared to placebo, BAFF levels decreased at 3, 6, and 9 months post-treatment initiation. APRIL levels were significantly reduced at the 3- and 6-month time points, while sBCMA levels decreased at the 6-month mark. These findings further support the potential disease-modifying effects of Nefecon in IgAN and highlight the importance of the gut–kidney axis in the disease’s pathogenesis.
Nefecon’s Development and Market Potential
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid known for its potent glucocorticoid activity. The formulation is designed as an enteric-coated capsule that remains intact until it reaches the Peyer’s patch region of the lower small intestine, targeting mucosal B-cells where the disease originates.
In June 2019, Everest Medicines secured an exclusive, royalty-bearing license agreement with Calliditas, granting it rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was expanded in March 2022 to include South Korea. Nefecon received priority review status in China in November 2022 and is anticipated to obtain marketing approval later this year.-Fineline Info & Tech
