SHANGHAI, Sept. 21, 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 it has entered into a collaboration and license agreement with Kezar Life Sciences ("Kezar"), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune mediated and oncologic disorders, to develop and commercialize Kezar's lead drug candidate zetomipzomib, a novel, first-in-class, selective inhibitor of the immunoproteasome for a range of autoimmune diseases including lupus nephritis (LN), in Greater China, South Korea and some Southeast Asian countries.
"We are glad to form a partnership with Kezar through our cooperation on zetomipzomib, which will add to our existing renal pipeline, and help solidify Everest's leading position in renal and autoimmune diseases in Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Renal and autoimmune diseases are key therapeutic areas for Everest and we look forward to working closely with our partner on the clinical trials, utilizing Everest's strong expertise in clinical development and regulatory filings, to bring this innovative therapy to the region as quickly as possible."
"Lupus Nephritis is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney function failure. In China alone, it is estimated that there are 1 million SLE patients in total, 40-60% SLE patients have renal disease, and the risk of mortality is significantly increased due to renal disease," said Zhengying Zhu, Ph.D., Chief Medical Officer for Internal Medicine at Everest Medicines. "Zetomipzomib can modulate innate and acquired immune responses to down regulate inflammation, which is differentiated from direct immunosuppression. This enables its treatment potential in a wide range of autoimmune diseases including LN and SLE."
"This partnership with Everest Medicines is an important milestone in the development of zetomipzomib," said John Fowler, co-founder and CEO of Kezar. "Everest stood out as an ideal regional partner due to its strong nephrology focus and outstanding team with deep global pharma experience. It is clear that they understand zetomipzomib's broad potential and that their team will integrate seamlessly with ours to help drive enrollment in PALIZADE, our global lupus nephritis trial. It's well-known that prevalence rates for many autoimmune diseases, including LN and SLE, are higher in Asia, and we are happy that even more patients in need will now get access to zetomipzomib as a result of this partnership."
Under the terms of the agreement, Kezar is entitled to receive an upfront payment of $7 million, and clinical and commercial milestone payments of up to $125.5 million, as well as tiered single-digit to low-teens royalties on net sales of products. Everest will also have the option to localize manufacturing.
Everest will join Kezar on PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. PALIZADE was initiated in mid-2023 and targets to enroll 279 patients. Data generated from prior clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile and LN patients showed a clinically meaningful overall renal response after 6 months of treatment with zetomipzomib. In addition to LN, Everest and Kezar have the opportunity to collaborate on future clinical trials and indications for the continued development of zetomipzomib.
Among Everest's renal pipeline, Nefecon®, the first-in-disease therapy for the treatment of primary immunoglobulin A nephropathy (IgAN), has been granted priority review for its NDA by the China National Medical Products Administration and is expected to get approval in the second half of this year. In addition, EVER001, a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, is in clinical development for the treatment of glomerular diseases. The company also has several programs at discovery stage with the most advanced candidate expected to file an IND next year. In the autoimmune space, Everest completed patient enrollment in a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis and aims to file NDA as soon as possible.
About Zetomipzomib
Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.
About the PALIZADE Trial
PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. Target enrollment will be 279 patients, randomly assigned (1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. Background therapy can, but will not be mandated to, include standard induction therapy. Over the initial 16 weeks, there will be a mandatory corticosteroid taper to 5 mg per day or less. End-of-treatment assessments will occur at Week 53. The primary efficacy endpoint is the proportion of patients who achieve a complete renal response (CRR) at Week 37, including a urine protein-to-creatine ratio (UPCR) of 0.5 or less without receiving rescue or prohibited medications.
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.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor that has completed a Phase 2 clinical trial in lupus nephritis. This product candidate also has the potential to address multiple chronic immune-mediated diseases.
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