Zetomipzomib

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

14 days ago

• 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.

FDA Clears Path for Nebokitug in Primary Sclerosing Cholangitis Treatment Following Successful Phase 2 Meeting

3 months ago

• Chemomab Therapeutics has secured FDA alignment for a streamlined phase 3 registration study of nebokitug (CM-101) in primary sclerosing cholangitis, marking a significant advancement in treatment development. • The innovative trial design eliminates the need for liver biopsy and will evaluate clinical events associated with disease progression as primary endpoints, simplifying the path to potential approval. • This development represents a major milestone in PSC treatment, as the trial could lead to the first regulatory approval based on a single pivotal study without requiring invasive diagnostic procedures.

Zymeworks Announces Strategic Priorities and Pipeline Expansion for 2025-2026

4 months ago

• Zymeworks is set to advance ZW171 and ZW191 in Phase 1 trials for solid tumors, part of their '5 by 5' R&D program. • The company plans to submit an IND application for ZW1528 in 2H-2026, targeting autoimmune and inflammatory diseases like COPD. • Regulatory decisions for zanidatamab in second-line biliary tract cancer in the EU and China are expected as early as 2Q-2025. • Zymeworks anticipates a cash runway into the second half of 2027, supported by $324 million in resources and milestone payments.

Lupus Nephritis Clinical Trial Landscape Shows Active Development

6 months ago

• The lupus nephritis clinical trial pipeline is robust, featuring over 30 companies developing more than 35 therapies. • Key players like AstraZeneca, Roche, and Novartis are advancing drugs such as Anifrolumab and Ianalumab through clinical trials. • Recent trial activities include Adicet Bio dosing the first patient in a Phase I trial of ADI-001 and Kyverna presenting updated clinical data on KYV-101. • Various therapeutic modalities, including monoclonal antibodies and cell therapies, are being explored across different clinical stages.

FDA Places Partial Clinical Hold on Kezar's Autoimmune Hepatitis Trial of Zetomipzomib

6 months ago

• 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.

FDA Halts Kezar's Lupus Nephritis Trial of Zetomipzomib Following Patient Deaths

8 months ago

• 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.

Kezar Life Sciences' Zetomipzomib Evaluated in Phase 2b PALIZADE Trial for Lupus Nephritis

9 months ago

• 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.