Everest Medicines Announces Topline Results from Chinese Subpopulation Consistent with Part A Analysis of NefIgArd Global Phase 3 Study

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SHANGHAI, April 5, 2022 /PRNewswire/ — Everest drugs (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Greater China and other parts of Asia, announced today that The results of proteinuria reduction and eGFR stabilization in a Chinese subpopulation after 9 months of NEFECON treatment are consistent with early results from Part A of the pivotal global Phase 3 NefIgArd clinical trial, which were reported in November 2020 by Calliditas Therapeutics AB (NASDAQ Global Select: CALT; NASDAQ Nordic: CALTX).

Everest Medicines secured exclusive licensing rights from Calliditas Therapeutics AB in 2019 to develop and commercialize NEFECON for the treatment of Primary IgA Nephropathy (IgAN) in Greater China and Singapore, which territory has been expanded to include Korea from the South in March this year.

“We are very pleased to see the data from the Chinese NefIgArd subpopulation that is consistent with the results from Part A of the global trial. This data will be included in regulatory filings in China in the second half of this year,” Zhengying Zhu said. , 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 November 2020, Calliditas reported that the main results of part A of the global trial provided evidence of a statistically significant reduction in proteinuria, after 9 months of treatment. The trial also met 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.

About NEFECON

NEFECON is a delayed-release oral formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes extensive first-pass metabolism. NEFECON has been designed as a 4 mg delayed release capsule and is enteric coated so that budesonide is released into the distal ileum. In June 2019, Everest Medicines entered into an exclusive, royalty-based license agreement with Calliditas, which grants Everest Medicines exclusive rights to develop and commercialize NEFECON in mainland China, Hong Kong, Macau, Taiwan and in Singapore. The agreement was extended in March 2022 to include South Korea as part of the Everest Medicine territories.

About the NeflgArd study

The NeflgArd global clinical trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of NEFECON once daily compared to placebo in adult patients with of primary IgAN (N = 360) in addition to optimized RASi therapy.

Part A of the study included a blinded treatment period of 9 months and a follow-up period of 3 months 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 met its primary objective in Part A of demonstrating a statistically significant reduction in urinary protein creatinine, UPCR, or proteinuria, after 9 months of treatment with 16 mg once daily of NEFECON compared to placebo. Patients taking NEFECON plus RASi (n=97) showed a statistically significant reduction of 34% from baseline versus 5% with RASi alone (n=102) at 9 months, p=0.0001.

About drugs Everest

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, CMC, business development and operations in China and with major global pharmaceutical companies. . Everest Medicines has built a portfolio of eleven potentially 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 diseases, cardio-renal diseases and infectious diseases. For more information, please visit their website at www.everestmedicines.com.

Forward-looking statements:

This press release may contain statements that constitute forward-looking statements, including descriptions regarding the current intention, belief or expectations of the Company or its officers with respect to the Company’s business activities and financial condition. , which can be identified by terminology such as “will”, “expect”, “anticipate”, “future”, “intend”, “plan”, “believe”, “estimate”, ” trust” and similar statements. These forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the Company’s control and cannot be predicted. Therefore, actual results may differ from those in forward-looking statements due to various factors and assumptions, such as future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives is under no obligation and does not undertake to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law. .

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SOURCE Everest Medicines


Company Codes: Hong Kong: 1952

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