Dazukibart Advanced Drug Monograph

Dazukibart Report

Name: Dazukibart Name (English): Dazukibart DrugBank ID: DB18429 Type: Biotech (Monoclonal Antibody) CAS Number: 2639474-65-8

Mechanism of Action: Dazukibart is a humanized IgG1κ monoclonal antibody that selectively binds to and neutralizes interferon-beta (IFN-β). By inhibiting IFN-β signaling, dazukibart aims to reduce the inflammatory response and modulate the immune system in autoimmune diseases characterized by type I interferon dysregulation.

Indications:

• Dermatomyositis
• Polymyositis
• Cutaneous Lupus Erythematosus
• Systemic Lupus Erythematosus
• Idiopathic Inflammatory Myopathies

Clinical Trials: Dazukibart is currently in various phases of clinical development:

• Phase 3: Recruiting for Myositis (Idiopathic Inflammatory Myopathies, including Dermatomyositis and Polymyositis) (NCT05895786, NCT06698796).
• Phase 2: Recruiting for Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus (NCT05879718).
• Phase 2: Completed a Phase 2 trial in adults with dermatomyositis (NCT03181893).
• Long-term Safety Study: Ongoing study to evaluate the long-term safety of dazukibart in patients with Idiopathic Inflammatory Myopathies (ClinicalTrials.eu).

Adverse Effects: In a Phase 2 trial for dermatomyositis, treatment-emergent adverse events were comparable between dazukibart and placebo groups, with infections and infestations being the most common. Serious adverse events were reported in some patients receiving dazukibart. One death occurred in the dazukibart 600 mg group during follow-up due to haemophagocytic lymphohistiocytosis and macrophage activation syndrome, although it was deemed unlikely related to the study medication.

Regulatory Status:

• European Medicines Agency (EMA): Orphan drug designation and PRIME designation for the treatment of dermatomyositis (granted January 6, 2021).
• U.S. Food and Drug Administration (FDA): Orphan drug and Fast Track designations for dermatomyositis.
• Dazukibart is not currently approved for marketing in any region.