Everest Medicines' Partner Calliditas Presents Nefecon Data at ERA-EDTA Congress

21 June 2023 | Wednesday | News

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress (ERA-EDTA), which was held in Milan, Italy, June 15-18.
Image Source : Public Domain

Image Source : Public Domain

The presentations showed data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon in patients with IgA nephropathy (IgAN). The study 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 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).  At 24 months, eGFR was reduced by 6.11 mL/min/1.73 m2 from baseline in the Nefecon arm compared with 12 mL/min/1.73 m2 reduction in the placebo arm, demonstrating 50% less loss of kidney function. Treatment benefit on eGFR was apparent across baseline urine protein creatinine ratio (UPCR) subgroups.

The reduction in UPCR was also durable, with a 30.7% decrease in UPCR in the Nefecon arm even after 15 months off drug compared with only 1% reduction in the placebo arm. Another analysis of the effect of durability of proteinuria reduction showed a 41% reduction in time-averaged UPCR over 12–24 months compared with placebo (95% CI 32-49%, p<0.0001).

For hematuria treatment, the proportion of patients with microhematuria in the Nefecon arm fell to 40.5% from 66.5% baseline while in the placebo arm, it only decreased to 61.2% from 67.8% baseline. 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 excited to see more evidence supporting Nefecon as a truly disease-modifying treatment for IgAN patients. The sustained effects on reduction of proteinuria and microhematuria were impressive, and more importantly, the data solidify Nefecon as a first-in-disease therapy for IgAN patients that can prevent 50% of kidney function loss observed in the placebo group," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Renal disease is a key focus area for Everest Medicines where we see significant unmet medical needs, particularly in Asia."

"China has the highest prevalence of primary glomerular diseases in the world with an estimated 5 million IgAN patients. Nefecon was the first innovative drug approved by FDA for the treatment of IgA nephropathy, and the ERA-EDTA congress was the first time that more complete data on the follow-up period after 9 months of treatment were disclosed," said Zhengying Zhu, Ph.D., Chief Medical Officer for Internal Medicine at Everest Medicines. "The significant and long-lasting clinical benefits establish Nefecon's leading position in the treatment of IgA nephropathy as a first-in-disease therapy. We hope to bring this medicine to patients in China and other Asian territories as soon as possible."

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. The NMPA has also granted Nefecon break-through therapy designation and priority review. Nefecon was the first non-oncology drug to receive break-through therapy designation in China.


Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in