Everest Medicines Announces that Licensing Partner Calliditas Therapeutics has Reported Positive Topline Results from Pivotal Phase 3 NefIgArd Trial
Shanghai, China—November 10, 2020 — 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 Asia, announced today that its licensing partner, Calliditas Therapeutics AB (NASDAQ: CALT) ("Calliditas"), reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon ®versus placebo in 199 patients with primary IgA nephropathy (IgAN).
The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. 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. The efficacy data indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease (ESRD) for IgAN patients. In addition, results showed that Nefecon was generally well-tolerated.
Based on these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. An additional 160 patients are being recruited for inclusion in Part B of the trial, which is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection.
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. Everest is currently enrolling patients as part of the global Phase 3 clinical trial to support approval for IgAN patients in China.
"We are very excited to see this strong set of data and look forward to building on these results as we continue to rapidly recruit patients with IgAN in China to support the NeflgArd trial," said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines.
"These encouraging data reinforce the potential for Nefecon to become the first approved treatment option for patients around the world with IgAN,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “There are an estimated 2 million people in China living with IgAN and we are committed to advancing this trial and work to make this important therapy available to patients in China."
Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer’s patch in the ileum, which is responsible for the production of secretory immunoglobulin A. Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 2b clinical trial conducted by our partner Calliditas Therapeutics AB (Nasdaq: CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). 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.
About IgA Nephropathy
IgA Nephropathy(IgAN) a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.
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 Greater China and other 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 eight 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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