China-based Everest Medicines (HKG: 1952) has announced the completion of patient enrollment for the China open-label extension (cOLE) of the Phase III NefIgArd study. This cOLE study provides an additional 9 months of treatment with Nefecon to all qualifying patients who have completed the NefIgArd study, aiming to evaluate the efficacy and safety of extended and repeated Nefecon treatment in patients with IgA nephropathy (IgAN).
Phase III NefIgArd Clinical Trial Overview
The Phase III NefIgArd clinical trial is a randomized, double-blind, multicenter study that assessed the efficacy and safety of Nefecon versus placebo on a background of optimized RAS inhibitor therapy. The study successfully met its primary endpoint, with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period. This included 9-months of treatment with Nefecon or placebo and 15-months of off drug follow-up. Patients in the cOLE study will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon at 16mg/day. The study will evaluate changes in eGFR and urine protein to creatinine ratio (UPCR) at the end of the treatment period.
Nefecon’s Unique Formulation and Mechanism
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated to release budesonide to the distal ileum.
Everest Medicines’ Licensing Agreement with Calliditas
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, securing exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories. The drug is anticipated to receive marketing approval in China later this year.-Fineline Info & Tech
