barzolvolimab

Action and Spectrum

Actions and Spectrum: 

Actions: 

Barzolvolimab, known as CDX 0159, is a humanized monoclonal antibody. It targets KIT IgG1, a key component. This antibody is   designed to stop KIT from activating, which is its primary purpose. In chronic inducible urticaria, barzolvolimab reduces skin mast cells and disease activity. It does this by inhibiting KIT activation, which is essential. Barzolvolimab may treat conditions with abnormal KIT activation and skin symptoms. It targets the underlying cause of chronic inducible urticaria, an innovative approach. 

Spectrum: 

In a double-blind placebo-controlled study, researchers tested Barzolvolimab (BAR/CDX-0159), an antibody against KIT, for safety and      effectiveness in treating chronic spontaneous urticaria (CSU) that doesn’t respond to antihistamines. Participants received BAR intravenously at different doses over 12 weeks. The study looked at safety, urticaria symptoms (weekly urticaria activity score, urticaria control test), and effects on tryptase levels in the blood. Out of 45 patients, some experienced side      effects like urinary tract infections, headaches, low white blood cell counts, and back pain, but nobody stopped treatment because of them. By week 8, patients receiving BAR showed   dose-dependent improvements – better urticaria control test scores, lower tryptase levels, and reduced weekly urticaria activity scores. Their symptoms improved quickly. These findings support further development of BAR as a potential new treatment for CSU that works by targeting mast cells in a unique way. Complete data from all BAR dose groups will be presented later. 

Drug Interaction

Adverse Reaction

Frequency defined 

Infusion related reactions (33%) 

Nasopharyngitis (67%) 

Hair color changes (78%) 

Taste disorders (44%) 

Black Box Warning

Limited data is available 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• Renal impairment 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy categories: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

Barzolvolimab is a monoclonal antibody created to target KIT, a receptor tyrosine kinase. It shows strong specificity and inhibits KIT activity powerfully, especially in mast cells. These cells play a crucial role in inflammatory responses like hypersensitivity and allergic reactions. The Phase 1b clinical trials assess barzolvolimab’s safety and efficacy for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) in antihistamine-resistant patients. For CSU, multiple ascending intravenous doses are given over 12 weeks. A single dose is evaluated in the CIndU trial involving inducible urticaria patients. Secondary goals include pharmacokinetic and pharmacodynamic assessments, clinical activity outcomes, and quality of life assessments. These trials comprehensively explore barzolvolimab’s potential for treating various urticaria forms. 

Pharmacodynamics: 

Limited data is available 

Pharmacokinetics: 

Limited data is available 

Adminstartion

Administration: 

Barzolvolimab travels into your body through a needle in your vein. The amount and how often depend on what illness you have. It is given with other medicines too. Scientists test it very carefully to ensure it is safe and works well. They give some people the real drug, some a fake one. No one knows which until the end. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: barzolvolimab 

Pronounced: bar-zol-voh-li-mab 

Why do we use barzolvolimab? 

Barzolvolimab, also known as CDX-0159, is a potential treatment for conditions like chronic spontaneous urticaria, chronic inducible urticaria, eosinophilic esophagitis, and prurigo nodularis. It is a second-generation version of CDX-0158, specifically targeting the tyrosine-protein kinase Kit. This drug can be administered through intravenous and subcutaneous routes. Originally explored for cancer treatment, its versatility showed promise. Current research focuses on evaluating its safety and effectiveness across various medical applications.