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SOUTH SAN FRANCISCO, Calif., May 28, 2019 (GLOBE NEWSWIRE) -- Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, today announced that data from the first two cohorts of an open-label dose escalation trial of KZR-616 in patients with systemic lupus erythematosus (SLE) will be featured in a poster presentation at the European League Against Rheumatism (EULAR) 2019 annual meeting taking place in Madrid, Spain June 12-15.
The full abstract, which is published on EULAR’s conference website, features preliminary results from the first two cohorts of the Phase 1b portion of the MISSION trial (Modulator of the Immunoproteasome for Systemic Lupus with and without Nephritis), which is evaluating KZR-616 in patients with SLE. Additional details regarding the trial, outcome measures, and patients enrolled will be presented at the meeting.
“Presenting our first in patient data with KZR-616, our novel selective immunoproteasome inhibitor, is an important milestone for Kezar and represents the culmination of several years of our team’s research and development efforts,” said Niti Goel, MD, FACR, Kezar’s Chief Medical Officer. “We are encouraged by the safety, tolerability, and potential efficacy seen thus far in the MISSION trial and look forward to sharing the detailed results with the clinical and scientific community next month. The Phase 2 portion in lupus nephritis patients has commenced enrollment, and we have identified 30 and 45mg as the appropriate doses to advance in each of our Phase 2 autoimmune clinical trials. We expect to initiate trials with KZR-616 in dermatomyositis, polymyositis, autoimmune hemolytic anemia, and immune thrombocytopenia later this year.”
Poster Presentation Details
Date and Time: Friday, June 14, 2019, 11:45am-1:30pm CET (Poster area, Hall 10)
Presenting Author: Richard Furie, MD, Chief of Rheumatology, Northwell Health, New York, USA
Abstract # FR0196: Treatment of Systemic Lupus Erythematosus Patients with the Immunoproteasome Inhibitor KZR-616: Results from the First 2 Cohorts of an Open-Label Phase 1b Dose Escalation Trial
KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Nonclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Phase 1a clinical trial results in healthy volunteers provide evidence that KZR-616 potentially avoids adverse effects caused by currently marketed non-selective proteasome inhibitors, which we believe prevent them from being utilized as a chronic treatment in autoimmune disorders. A Phase 1b/2 trial (MISSION study) of KZR-616 in systemic lupus erythematosus (SLE) patients and lupus nephritis (LN) patients is currently underway. Phase 2 trials in dermatomyositis (DM), polymyositis (PM), autoimmune hemolytic anemia (AIHA), and immune thrombocytopenia (ITP) are expected to commence in the second half of 2019.
About the MISSION Study
The MISSION study (NCT03393013) is a Phase 1b/2 multi-center study in which patients receive weekly subcutaneous injections of KZR-616 for 13 weeks. The study consists of 2 parts. The Phase 1b portion is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with SLE with and without nephritis. The Phase 2 portion is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative LN.
About Kezar Life Sciences
Based in South San Francisco, Kezar Life Sciences is a clinical-stage biotechnology company committed to revolutionizing treatments for patients with autoimmune diseases and cancer. Kezar is translating its innovative research on the immunoproteasome and protein secretion pathways to advance novel therapeutic approaches. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe autoimmune diseases. Additionally, Kezar plans to nominate an initial clinical candidate for the treatment of cancer from its protein secretion program before the end of the year. For more information, visit www.kezarlifesciences.com.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “expect,” “plans,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, the safety, tolerability and potential efficacy of KZR-616, the dosage levels to be utilized in current and future clinical trials, the initiation, enrollment and timing of clinical trials, and the nomination of product candidates for clinical development. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
SVP, Strategy & External Affairs