SHANGHAI, April 5, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asiaannounced today that the findings of reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment with NEFECON are in line with topline results from Part A of the pivotal global Phase 3 clinical trial NefIgArd, which were reported in October 2020 by Calliditas Therapeutics AB (NASDAQ Global Select: CALT; NASDAQ Nordic: CALTX).
Everest Medicines secured exclusive license rights from Calliditas Therapeutics AB in 2019 to develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in Greater China and Singaporewhich territory was expanded to include south korea in March of this year.
“We are very pleased to see data from the Chinese subpopulation of NefIgArd that are consistent with the results of Part A of the global trial. These data will be included in regulatory filings in China in the second half of this year,” said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines. “We hope to bring this innovative treatment to IgAN patients in China and other markets as soon as possible.”
In October 2020Calliditas reported that topline results from Part A of the global trial provided evidence of a statistically significant reduction in proteinuria, after 9 months of treatment. The trial also puts the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. NEFECON was generally well-tolerated.
NEFECON is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that budesonide is released to the distal ileum. In June 2019Everest 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.
About the NeflgArd Study
The global clinical trial NeflgArd is an ongoing Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of NEFECON once daily vs placebo in adult patients with primary IgAN (N=360) as an addition to optimized RASi therapy.
Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period for 200 patients. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B, the ongoing confirmatory validation study, will assess eGFR over two years in all 360 patients.
The global trial puts its primary objective in Part A of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg ounce daily of NEFECON compared to placebo. Patients taking NEFECON plus RASi (n=97) showed a statistically significant 34% reduction from baseline vs 5% with RASi alone (n=102) at 9 months, p=0.0001.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products 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 of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven 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 oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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SOURCE Everest Medicines