Everest Medicines' Partner Calliditas Therapeutics Makes Data Presentations on Nefecon at European Renal Association - European Dialysis and Transplant Association Congress (ERA-EDTA )

Rhea-AI Summary

Everest Medicines partner, Calliditas Therapeutics, presented data from the NeflgArd Phase 3 Study at a medical congress. The study showed that Nefecon, a treatment for IgA nephropathy, demonstrated significant benefits over placebo, including a 50% reduction in kidney function loss. The treatment also showed sustained effects on reducing proteinuria and microhematuria. Chinese subpopulation results are expected in Q3 2023.

Positive

• Nefecon demonstrated a highly statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over a two-year period, with an average increase of 5.05 mL/min/1.73 m2 compared to placebo. The reduction in kidney function loss was 50% less in the Nefecon arm compared to placebo. The treatment also showed significant and long-lasting clinical benefits, establishing it as a first-in-disease therapy for IgA nephropathy. The China National Medical Products Administration has accepted the New Drug Application for Nefecon and granted it breakthrough therapy designation and priority review.

Negative

• None.

SHANGHAI, June 20, 2023 /PRNewswire/ -- 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.

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.

About Nefecon 

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 so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

Nefecon was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

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SOURCE Everest Medicines

FAQ

What is the NeflgArd Phase 3 Study?

The NeflgArd Phase 3 Study is a clinical trial evaluating Nefecon in patients with IgA nephropathy.

What were the results of the study?

The study showed that Nefecon demonstrated a highly statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over a two-year period, with an average increase of 5.05 mL/min/1.73 m2 compared to placebo. It also showed a 50% reduction in kidney function loss compared to placebo.

What is IgA nephropathy?

IgA nephropathy is a kidney disease characterized by the buildup of the antibody immunoglobulin A (IgA) in the kidneys.

What is proteinuria?

Proteinuria is the presence of excess protein in the urine, which is a common symptom of kidney disease.

What is microhematuria?

Microhematuria is the presence of blood in the urine that is not visible to the naked eye. It is also a common symptom of kidney disease.

What is breakthrough therapy designation?

Breakthrough therapy designation is a status granted by regulatory agencies, such as the China National Medical Products Administration, to expedite the development and review of drugs that show significant benefits over existing treatments for serious or life-threatening conditions.