Business
Kezar Life Sciences Reports Third-Quarter 2020 Financial Results and Provides Business Updates
FDA grants two Orphan Drug Designations to KZR-616 for the treatment of Dermatomyositis (DM) and Polymyositis (PM) KZR-616 clinical and pre-clinical data
About this update from Kezar Life Sciences, Inc.
[{"type":"text","content":"\n\nFDA grants two Orphan Drug Designations to KZR-616 for the treatment of Dermatomyositis (DM) and Polymyositis (PM) \n\n\nKZR-616 clinical and pre-clinical data continues to support its potential to positively affect multiple drivers of immune-mediated diseases\n\n\nKZR-261 IND submission on-track for Q1 2021\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nKezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced its third-quarter 2020 financial results and corporate highlights.\n\n“The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis and dermatomyositis,” said John Fowler, Kezar’s Co-Founder and Chief Executive Officer. “In addition, our presentations at a number of medical and scientific meetings this fall highlight the compelling therapeutic potential of our two highly novel programs in immunoproteasome inhibition and the protein secretion pathway. With each step forward, our conviction deepens that Kezar’s novel small molecule approaches in autoimmunity and oncology could have profound impacts on a wide array of diseases with high unmet need.”\n\nClinical Highlights & Updates\n\nKZR-616: Selective Immunoproteasome Inhibitor\n\nKZR-616 is currently being evaluated for the treatment of severe autoimmune diseases.\n\n\nIn October 2020, Orphan Drug Designations (ODD) were granted for KZR-616 in both dermatomyositis (DM) and polymyositis (PM) by the U.S. Food and Drug Administration (FDA). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of DM and PM in the United States is up to 71,000 and 51,000, respectively. Orphan Drug Designation can provide certain benefits for the development of KZR-616, including a period of marketing exclusivity for the first marketing application, if approved for the designated indication, certain tax credits and waiver of certain administrative fees.\n\n\n\nThe MISSION Phase 2 trial in patients with active, proliferative lupus nephritis (LN) opened for enrollment under a new protocol in August 2020. The p...