Kezar Life Sciences, Inc. is a clinical-stage biopharmaceutical company which engages in the development of novel small molecule therapeutics to treat autoimmunity and cancer. Its product pipeline includes KZR-616, KZR-261, and KZR-TBD. The company was founded by John Fowler, Christopher J. Kirk, and Jack Taunton on February 20, 2015 and is headquartered in South San Francisco, CA.
相关临床试验
16
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2015
进行中（未招募）
3
18.8%
已完成
5
31.3%
尚未招募
1
6.3%
招募中
4
25.0%
终止
2
12.5%
撤回
1
6.3%
暂无批准数据
- Kezar Life Sciences was unable to align with the FDA on a registrational trial for zetomipzomib in autoimmune hepatitis after the agency cancelled a scheduled Type C meeting and requested additional hepatic impairment studies. - The FDA's requirements would delay future zetomipzomib trials by approximately 2 years and mandate 48-hour patient monitoring in clinical research units, which could hinder enrollment. - Despite positive Phase 2a PORTOLA trial results showing 36% of steroid-dependent patients achieved biochemical remission with zetomipzomib versus 0% with placebo, the company is now exploring strategic alternatives. - Zetomipzomib represents a novel first-in-class selective immunoproteasome inhibitor targeting autoimmune hepatitis, a rare disease affecting approximately 100,000 Americans with no FDA-approved treatments.
- Aligos Therapeutics has appointed Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), bringing over 20 years of pharmaceutical development experience to the company. - The appointment comes at a strategic time as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 for liver and viral diseases. - Dr. Wesson previously led CMC operations at Kezar Life Sciences and AN2 Therapeutics, and supported the approval and commercial launches of Kerydin® and Eucrisa® at Anacor Pharmaceuticals. - The hire reinforces Aligos' commitment to advancing its pipeline of therapeutics targeting chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
• Merck KGaA has decided to progress its experimental lupus treatment to Phase III clinical trials despite reporting mixed efficacy data from earlier studies. • The advancement comes amid significant developments in the lupus treatment landscape, including UCB and Biogen's successful Phase III results for dapirolizumab pegol announced in September 2024. • The lupus therapeutic area has seen recent setbacks as well, with Kezar Life Sciences discontinuing its lupus nephritis program in October 2024 following four patient deaths in their Phase IIb PALIZADE study.
- The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. - Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. - Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
• The FDA has placed a partial clinical hold on Kezar's PORTOLA Phase IIa study of zetomipzomib in autoimmune hepatitis patients, following a previous hold on a lupus nephritis trial. • The hold restricts new patients from entering the open-label extension, but allows current participants to continue treatment with adjusted prednisone dosage. • Kezar is investigating safety events from the lupus nephritis trial to guide patient management in ongoing and future zetomipzomib studies. • Topline data from the PORTOLA trial, evaluating complete biochemical response after 24 weeks, is expected in the first half of 2025.
• Kezar Life Sciences halted the Phase II clinical trial of KZR-616 after five patients died during the study, raising concerns about the drug's safety profile. • The trial was investigating KZR-616 as a potential treatment for various autoimmune diseases, including systemic lupus erythematosus, dermatomyositis, and polymyositis. • Kezar is evaluating the data to determine the cause of the deaths and the future of the KZR-616 program, its only active drug. • The company's stock price plummeted following the announcement, reflecting investor concerns about the future of Kezar's pipeline.
• The FDA has placed a clinical hold on Kezar Life Sciences' zetomipzomib IND application for lupus nephritis treatment after four patient deaths. • Kezar voluntarily suspended enrollment in the Phase 2b PALIZADE trial following safety concerns raised by the Independent Data Monitoring Committee (IDMC). • The IDMC reported a pattern of symptoms and proximity to dosing in the fatal cases, prompting further investigation and potential risk mitigation strategies. • Kezar's zetomipzomib IND for autoimmune hepatitis remains unaffected, with the Phase 2a PORTOLA trial continuing without similar safety concerns.
• The PALIZADE trial is a Phase 2b study assessing zetomipzomib (KZR-616) for treating active lupus nephritis, a severe complication of systemic lupus erythematosus. • The trial randomizes patients to either 30 mg or 60 mg of zetomipzomib, or placebo, administered weekly via subcutaneous injection over a 52-week period. • Key inclusion criteria include a kidney biopsy confirming active lupus nephritis and specific urine protein to creatinine ratio (UPCR) thresholds. • The global study, involving sites in 21 countries, evaluates the efficacy and safety of zetomipzomib, with accommodations available for study participation.
