The primary objective of the cOLE study is to assess the efficacy and safety of extended and repeated Nefecon treatment in patients with IgA Nephropathy (IgAN)
Everest Medicines completes patient recruitment in Nefecon China open-label extension study. (Credit: Chokniti Khongchum from Pixabay)
Everest Medicines has enrolled patients for the China open-label extension (cOLE) of the Phase 3 NefIgArd study.
This extension study will provide an additional nine months of treatment with Nefecon to eligible patients who have completed the NefIgArd study.
The primary objective of the cOLE study is to assess the efficacy and safety of extended and repeated Nefecon treatment in patients with IgA Nephropathy (IgAN).
The Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that compared the efficacy and safety of Nefecon to a placebo in combination with optimized RAS inhibitor therapy. The study achieved 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, including 9 months of treatment with Nefecon or placebo and a 15-month off-drug follow-up period.
In the cOLE study, patients will continue their RAS inhibitor therapy (ACEs and/or ARBs) and receive Nefecon at a dosage of 16mg/day for 9 months. At the end of this treatment period, changes in eGFR and urine protein to creatinine ratio (UPCR) will be evaluated to further assess the efficacy and safety of Nefecon in managing IgA Nephropathy.
This milestone in patient enrolment marks a significant step forward for Everest Medicines’ efforts in developing and commercialising innovative medicines and vaccines, particularly for the treatment of IgA Nephropathy, a condition with unmet medical needs. The data from the cOLE study will contribute valuable insights into the potential benefits of extended Nefecon treatment for patients with this challenging kidney disease.
Everest Medicines CEO Rogers Yongqing Luo said: “The results of the cOLE study will offer insight into the value of extended and repeated use of Nefecon and provide very important guidance for doctors in clinical practice.”
The acceptance of Everest Medicines’ New Drug Application (NDA) for Nefecon by the China National Medical Products Administration (NMPA) in November 2022 marks a significant regulatory milestone for the treatment of IgA Nephropathy (IgAN) in China. This acceptance indicates that the NMPA has officially begun the review process for Nefecon as a potential therapeutic option for patients with IgAN.