Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”) announced today that its partner Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))))) (“Calliditas”) reported positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN).
The trial 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 of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug. The analysis included 364 patients diagnosed with primary IgAN and who were on a background of optimized and stable renin-angiotensin system (RAS) inhibitor therapy. The patients were randomized in a 1:1 ratio into one of two treatment groups – Nefecon 16 mg/day orally or placebo – and treated for 9 months daily, and then monitored for 15 months off-drug.
The key primary endpoint, eGFR over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon compared to placebo (p<0.0001). Mean change in eGFR over the 2-year period was -2.47 mL/min/1.73 m2 for Nefecon 16 mg versus -7.52 mL/min/1.73 m2 for placebo. A treatment benefit on eGFR was apparent across baseline UPCR subgroups, and sustained proteinuria effects and long lasting eGFR treatment benefit were observed even after 15 months after discontinuation, supporting disease modification. The results also indicate that Nefecon was generally well-tolerated and the safety profile was consistent with that observed in Part A of the trial.
“We are very excited to see Nefecon’s sustained impact on kidney function across the entire study population, that demonstrates its effect as a truly disease modifying first-in-disease treatment for IgAN patients. The sustained effects on proteinuria and on eGFR offer a specially designed treatment for IgAN patients at risk of progressive kidney function loss,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Chronic kidney disease is one of the most serious public health problems in China, where IgAN affects around five million people. Following Nefecon’s approval and commercialization in U.S. and E.U, we hope to bring this novel therapy to Chinese patients as soon as possible this year.”
This data readout from Part B provides longer term data from the Phase 3 NefIgArd trial, which read out topline data on Part A in November 2020. On the basis of this new data, Calliditas plans to file for full approval from the FDA, and support filing for full approval with EC and UK MHRA during 2023.
Chinese subpopulation Part B topline results are expected to be available in Q3, 2023. The China National Medical Products Administration (NMPA) accepted Everest Medicines’ New Drug Application (NDA) for Nefecon for the treatment of IgAN in November 2022 and has also been granted break-through therapy and priority review. Nefecon was the first non-oncology drug to receive break-through therapy designation in China.