Kezar Life Sciences Halts Lupus Drug Trial Amid Safety Concerns
Kezar Life Sciences Pauses Lupus Nephritis Clinical Trial
Kezar Life Sciences, Inc. (NASDAQ: KZR) has made the significant decision to pause its Phase 2b PALIZADE clinical trial aimed at treating lupus nephritis. This action follows guidance from the Independent Data Monitoring Committee (IDMC), which was prompted by reports of concerning safety data linking to the trial.
Overview of the Trial Suspension
The IDMC reported four fatal serious adverse events (SAEs) among participants from regions including the Philippines and Argentina. Investigators noted that three of these fatalities exhibited a similar symptom profile and timing associated with drug dosing. In this context, Kezar has maintained that it's uncertain whether the patients received the experimental drug, zetomipzomib, or a placebo, as the study is blinded.
Current Enrollment and Objectives
As it stands, 84 individuals are part of the PALIZADE trial, which aims to assess the effectiveness and safety of zetomipzomib for active lupus nephritis (LN). The suspension will afford Kezar the necessary time to evaluate the safety data and consider ways to address potential risks moving forward.
Perspective from Leadership
Dr. Chris Kirk, CEO of Kezar, reaffirmed the company's unwavering commitment to patient safety and the urgency of discovering viable therapies for serious conditions like lupus nephritis. He also noted the importance of collaborating with site investigators and regulatory bodies in reviewing these incidents to decide on the direction of the zetomipzomib program.
Regulatory Communication and Other Trials
Kezar has taken steps to notify study investigators and regulatory agencies, including the FDA and the European Medicines Agency, about the trial's pause. However, there has yet to be a formal clinical hold issued for the Investigational New Drug application. The company does plan to release further updates regarding the investigation into the recent developments.
Ongoing Trials and Financial Status
Importantly, this pause leaves Kezar's Phase 2a PORTOLA trial of zetomipzomib for autoimmune hepatitis unaffected, as it remains active and completed enrollment without any observed high-grade SAEs.
In light of recent financial developments, Kezar reported a net loss of $22 million for the second quarter, holding cash reserves of $164 million, which are projected to sustain operations into late 2026. The timeline for analyzing Autoimmune Hepatitis (AIH) treatment data has also been postponed, now expected in early 2025.
International Dosing Developments
In an encouraging announcement, Kezar revealed that dosing has commenced in China for its drug candidate addressing lupus nephritis, under a deal with Everest Medicines. This trial is on track, with preliminary results anticipated by mid-2026. Meanwhile, focusing on their key drug, the company has discontinued another candidate, KZR-261, to devote resources to the trials of zetomipzomib.
Market Reactions and Future Prospects
Following these developments, TD Cowen has reiterated a 'Buy' rating for Kezar Life Sciences, noting the firm’s strategic adjustments and strength in its financial footing. As the company shifts focus towards the future of its development programs, the recent suspension of the trial raises significant questions about its impact on Kezar's overall market position.
Frequently Asked Questions
What led to the suspension of Kezar Life Sciences' clinical trial?
The trial was paused due to recommendations from the Independent Data Monitoring Committee following reports of serious adverse events, including fatalities among participants.
What is zetomipzomib, and how does it relate to the clinical trial?
Zetomipzomib is a drug candidate under investigation for its effectiveness in treating lupus nephritis as part of the PALIZADE trial.
How many patients were enrolled in the PALIZADE trial?
A total of 84 patients were enrolled in the PALIZADE clinical trial before its suspension.
Does the suspension affect other ongoing trials by Kezar?
No, the suspension does not impact the ongoing Phase 2a PORTOLA trial for autoimmune hepatitis, which continues without complications.
What are Kezar Life Sciences' immediate next steps after this pause?
Kezar plans to conduct a thorough review of the safety data and work with regulatory authorities to assess the future of the zetomipzomib program.
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