SHANGHAI, August 1, 2023 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today the completion of patient enrollment for the China open-label extension (cOLE) of the Phase 3 NefIgArd study. The cOLE study offers an additional 9 months of treatment with Nefecon® to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of extended and repeated Nefecon® treatment in patients with IgA Nephropathy (IgAN).
The Phase 3 NefIgArd clinical trial is a randomized, double-blind, multicenter study which assessed the efficacy and safety of Nefecon® versus placebo on a background of optimized RAS inhibitor therapy. 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 off drug follow-up. Patients in the cOLE study will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon® at 16mg/day. At the end of the treatment period, change in eGFR and urine protein to creatinine ratio (UPCR) will be evaluated.
“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,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.
The China National Medical Products Administration (NMPA) accepted Everest’s 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 NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China.
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.
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.