Kezar Life Sciences Updates on Clinical Trials for Zetomipzomib
Kezar Life Sciences, Inc. (Nasdaq: KZR), a biotechnology company focused on developing innovative therapeutics for immune-mediated diseases, has provided important updates on its clinical trials. The Independent Data Monitoring Committee (IDMC) overseeing the PORTOLA Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH) has recommended that the trial continue without modifications after a thorough safety review. This trial is on track to deliver topline data in the first half of 2025.
Conversely, the company has decided to terminate the PALIZADE Phase 2b clinical trial for active lupus nephritis (LN) to concentrate resources on the development of zetomipzomib for AIH. The PALIZADE trial was placed on clinical hold due to the IDMC’s concerns regarding four Grade 5 serious adverse events (SAEs) among participants in the Philippines and Argentina, including one in a placebo group. As of the decision to discontinue, 84 patients had been enrolled, and the company plans to conduct a comprehensive investigation into the safety events before releasing available data from the trial.
Chris Kirk, PhD, CEO of Kezar, expressed optimism about the PORTOLA trial’s continuation, highlighting the potential of zetomipzomib as a significant treatment option for AIH patients. While acknowledging disappointment in pausing the LN program, Kirk emphasized that refocusing on AIH would extend the company’s cash runway and allow for greater flexibility in advancing zetomipzomib for this critical need.
As of September 30, 2024, Kezar’s unaudited cash position is approximately $148 million, covering cash, cash equivalents, and marketable securities.
About the PORTOLA Trial
The PORTOLA trial is a placebo-controlled, randomized, double-blind Phase 2a study evaluating the efficacy and safety of zetomipzomib in patients with AIH who are not adequately responding to standard treatments or have relapsed. It has enrolled 24 patients, randomized to receive either 60 mg of zetomipzomib or a placebo alongside background therapy for 24 weeks. The primary endpoint measures the proportion of patients achieving complete biochemical response by Week 24.
About Autoimmune Hepatitis
Autoimmune hepatitis (AIH) is a rare chronic condition where the immune system attacks the liver, leading to inflammation and damage. If untreated, it can result in severe health complications, including cirrhosis and liver failure. In the U.S., approximately 140,000 individuals are affected by AIH, with women being disproportionately affected. Current treatments often involve chronic immunosuppressive therapy, which can cause significant side effects, underscoring the need for safer and more effective treatment options.
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.
