Everest Medicines and Calliditas recently completed patient enrollment for the China open-label extension (cOLE) study of Nefecon, an oral medication designed to address IgA Nephropathy (IgAN), a kidney disease. Nefecon incorporates a patented budesonide formulation that underwent extensive research and development to ensure effective delivery to the targeted site.
In June 2019, Everest Medicines and Calliditas joined forces in an exclusive collaboration granting Everest Medicines rights to develop and market Nefecon in specific Asian regions. With a successful track record in pharmaceutical development, Everest Medicines is renowned for its expertise in the field.
The China open-label extension (cOLE) study is an extension of the Phase 3 NefIgArd clinical trial, which compared Nefecon to a placebo alongside optimized RAS inhibitor therapy. Notably, Nefecon exhibited a significant improvement in the estimated glomerular filtration rate (eGFR) during the initial 9-month treatment phase, with a follow-up period of 15 months to assess the drug’s lasting effects.
Drawing upon this achievement, patients who qualify and have finished the NefIgArd study will now participate in the cOLE study, where they will undergo an additional 9-month course of treatment with Nefecon. The primary objective of this extension study is to assess the effectiveness and safety of using Nefecon over an extended and repeated period in patients diagnosed with IgA Nephropathy (IgAN).
During the cOLE study, patients will continue to receive RAS inhibitor therapy while being administered a daily dose of 16mg of Nefecon for the 9-month duration. The researchers will closely monitor changes in eGFR and the urine protein to creatinine ratio (UPCR) to assess the drug’s effects.
Everest Medicines’ CEO, Rogers Yongqing Luo, expressed confidence that the study results would offer valuable insights into the extended and repeated use of Nefecon, which would be beneficial for doctors in their clinical practice. This continuation study holds promise for patients suffering from IgAN and could pave the way for improved treatment options and outcomes.
It is worth noting that Nefecon received approval for treating IgAN from the China National Medical Products Administration (NMPA) in November 2022. This milestone was further enhanced by the drug’s breakthrough therapy designation and NDA priority review from the NMPA, an exceptional recognition for non-oncology drugs in China.