SOUTH SAN FRANCISCO, Calif. - Kezar Life Sciences , Inc. (NASDAQ:KZR), a biotech firm focused on developing treatments for immune-mediated diseases, has paused its Phase 2b PALIZADE clinical trial for lupus nephritis. The decision follows a recommendation from the Independent Data Monitoring Committee (IDMC) after a review of safety data revealed four Grade 5 (fatal) serious adverse events (SAEs) among trial participants in the Philippines and Argentina.
The IDMC noted that three of the fatalities shared a pattern of symptoms and timing related to dosing. Additional non-fatal SAEs also displayed a similar proximity to dosing. Kezar has maintained a blind study, meaning it is unknown whether the affected patients received zetomipzomib, the drug under trial, or a placebo. The company has not reported any deaths or serious opportunistic infections in previous studies of zetomipzomib.
As of now, 84 patients have been enrolled in the PALIZADE trial, which aims to evaluate the efficacy and safety of zetomipzomib in treating active lupus nephritis (LN), a severe complication of systemic lupus erythematosus (SLE). The trial's cessation will allow Kezar to assess the safety data thoroughly and consider potential risk mitigation strategies.
Kezar's CEO, Chris Kirk, PhD, emphasized the company's commitment to patient safety and the importance of developing new therapies for life-threatening medical conditions like lupus nephritis. He stated that Kezar would work closely with site investigators and regulatory authorities to review the cases and determine the future of the zetomipzomib development program.
The company has informed study investigators of the pause and is in the process of notifying regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. No formal Investigational New Drug clinical hold has been issued at this time. Kezar will provide additional information regarding the investigation and development program when appropriate.
This suspension does not affect Kezar's Phase 2a PORTOLA clinical trial of zetomipzomib for autoimmune hepatitis, which has completed enrollment and remains active without any observed Grade 4 or 5 SAEs.
The information reported is based on a press release statement from Kezar Life Sciences, Inc.
In other recent news, Kezar Life Sciences continues to be in the spotlight with its financial update and strategic decisions. The company reported a second-quarter net loss of $22 million and cash reserves of $164 million, projected to last until late 2026. Kezar also announced an adjustment in the timeline for its Autoimmune Hepatitis (AIH) treatment data, now expected in the first half of 2025.
In terms of clinical trials, Kezar revealed that the first patient in China has been dosed with zeto, its drug candidate for Lupus Nephritis (LN), under a licensing agreement with Everest Medicines. The LN trial is progressing as planned, with top-line results anticipated by mid-2026. As a strategic decision, Kezar has discontinued the development of another drug candidate, KZR-261, to focus its resources on zeto's trials.
TD Cowen reiterated a Buy rating for Kezar following these recent developments. The analyst noted the company's strategic decisions and financial position, emphasizing the shift in focus to zeto trials. These are the latest highlights from the company's recent news.
InvestingPro Insights
The recent suspension of Kezar Life Sciences' (NASDAQ:KZR) Phase 2b PALIZADE clinical trial has significant implications for the company's financial outlook and market position. According to InvestingPro data, Kezar's market capitalization stands at a modest $39.68 million, reflecting the challenges faced by the biotech firm.
InvestingPro Tips highlight that Kezar is "quickly burning through cash" and "suffers from weak gross profit margins." These factors are particularly concerning given the recent trial suspension, which may further strain the company's financial resources. The gross profit margin for the last twelve months as of Q2 2023 stands at an alarming -1040.71%, underscoring the company's struggle to generate profits from its operations.
Despite these challenges, it's worth noting that Kezar "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations," according to InvestingPro Tips. This financial cushion could prove crucial as the company navigates the current setback and potentially explores alternative development paths for zetomipzomib.
The stock is currently trading near its 52-week low, with a one-year price total return of -54.29%. This performance reflects investor concerns about the company's prospects, especially in light of the recent clinical trial pause.
For investors seeking a more comprehensive analysis, InvestingPro offers 10 additional tips for Kezar Life Sciences, providing a deeper understanding of the company's financial health and market position.
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