Kezar Life Sciences to Present at Virtual KOL Event Hosted by William Blair on Zetomipzomib Clinical Development in Autoimmune Hepatitis and Provide a Safety Update from the PALIZADE Trial for Lupus Nephritis on February 27, 2025

Rhea-AI Summary

Kezar Life Sciences (Nasdaq: KZR) announced a virtual Key Opinion Leader (KOL) event hosted by William Blair on February 27, 2025, at 4:00 p.m. ET. The event will focus on zetomipzomib clinical development in autoimmune hepatitis (AIH) and provide a safety update from the PALIZADE Phase 2b trial for lupus nephritis (LN).

Dr. Aparna Goel from Stanford University will discuss AIH patient burden, current treatments, and future treatment landscape. The company will present an overview of the PORTOLA Phase 2a trial of zetomipzomib in AIH patients, with topline data expected in H1 2025. Additionally, a safety update will be provided for the PALIZADE Phase 2b trial, which was discontinued and unblinded in October 2024.

Positive

• PORTOLA Phase 2a trial for AIH has completed enrollment
• Topline data from PORTOLA trial expected in H1 2025

Negative

• PALIZADE Phase 2b trial for lupus nephritis was discontinued and unblinded in October 2024

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that it will present at a virtual Key Opinion Leader (KOL) event hosted by William Blair on zetomipzomib clinical development in autoimmune hepatitis (AIH) and will also provide a safety update from the PALIZADE Phase 2b clinical trial in patients with active lupus nephritis (LN) on Thursday, February 27, 2025, at 4:00 p.m. ET.

The event will feature Aparna Goel, MD, a general transplant and hepatologist at Stanford University, who will discuss the burden of autoimmune hepatitis (AIH) on patients, current treatments and unmet needs, and expectations for how the treatment landscape will evolve in coming years. Zung To, SVP of Clinical Development, will also provide an overview of the PORTOLA Phase 2a clinical trial of zetomipzomib in patients with AIH. Kezar has completed enrollment of PORTOLA and plans to report topline data in the first half of 2025.

Rachel Peterson, MD, Head of Clinical Immunology, will provide a safety update from the PALIZADE Phase 2b clinical trial of zetomipzomib in patients with active LN, which was discontinued and unblinded in October 2024.

A live question and answer session will follow the formal presentation.

The event will be hosted by Matt Phipps at William Blair. To register for this event, please go to https://williamblair.zoom.us/webinar/register/WN_HRwLHXKiQ3WcYPs0NEZ0eA.

A replay of the event will be available for 60 days following the presentation on the Kezar website on the "Events & Presentations" page.

About Aparna Goel, MD

Dr. Goel is an Associate Professor of Medicine at Stanford University. She is a transplant hepatologist in the Division of Gastroenterology and Hepatology with a specific clinical and research interest in autoimmune liver diseases including autoimmune hepatitis, primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). She serves as the principal investigator on several clinical trials related to these autoimmune liver diseases. She is the Program Director of the ACGME Transplant Hepatology Fellowship and the Associate Program Director of the Gastroenterology Fellowship at Stanford.

About PORTOLA

PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. The study has completed enrollment of 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. The primary efficacy endpoint will measure the proportion of patients who achieve a complete biochemical response by Week 24 measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.

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,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” 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 Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of clinical trials, the enrollment and expected timing of reporting topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other 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.

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Investor and Media Contact:

Gitanjali Jain

Senior Vice President, Investor Relations and External Affairs

Kezar Life Sciences, Inc.

gjain@kezarbio.com

Source: Kezar Life Sciences, Inc.

FAQ

When will Kezar Life Sciences (KZR) report PORTOLA Phase 2a trial topline data for autoimmune hepatitis?

Kezar Life Sciences plans to report topline data from the PORTOLA Phase 2a trial in the first half of 2025.

Why was the KZR PALIZADE Phase 2b trial for lupus nephritis discontinued?

The press release indicates that the PALIZADE Phase 2b trial was discontinued and unblinded in October 2024, but does not specify the reason for discontinuation.

What is the status of KZR's PORTOLA Phase 2a trial for autoimmune hepatitis?

Kezar has completed enrollment of the PORTOLA Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis.

When is Kezar's (KZR) KOL event for zetomipzomib clinical development?

The virtual KOL event is scheduled for February 27, 2025, at 4:00 p.m. ET.