Pharma Focus Europe

Celldex Initiates Phase 2 Study of Barzolvolimab for Eosinophilic Esophagitis With First Patient Dosed

Friday, July 07, 2023

Celldex Therapeutics, Inc. (NASDAQ:CLDX) has announced the initiation of a Phase 2 study for barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease affecting the esophagus. The first patient has been treated in this subcutaneous study, which aims to evaluate the effectiveness and safety of barzolvolimab in patients with active EoE. Mast cells are believed to play a significant role in the disease, along with eosinophils, as mast cells have been found in the biopsy tissue of some patients who continue to experience symptoms despite eosinophil depletion. Barzolvolimab is a humanized monoclonal antibody designed to bind to and inhibit the activity of the receptor tyrosine kinase KIT, which is vital for the survival and function of mast cells.

Dr. Diane C. Young, Senior Vice President and Chief Medical Officer of Celldex Therapeutics, highlighted the importance of investigating cell types other than eosinophils, particularly mast cells, in the context of EoE. The study of barzolvolimab's potential as a mast cell depleting agent in EoE may provide valuable insights for future development in other gastrointestinal (GI) disorders.

The Phase 2 study is a randomized, double-blind, placebo-controlled trial that will involve approximately 60 patients with active EoE. The participants will be randomly assigned in a 1:1 ratio to receive either subcutaneous injections of barzolvolimab at a dose of 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment phase. Following this phase, there will be a 12-week active treatment phase, during which all patients will receive barzolvolimab at a dose of 300 mg every 8 weeks. A 16-week follow-up phase will then be conducted. The primary endpoint of the study is to assess the reduction of mast cell infiltration in the esophagus, measured by the peak esophageal intraepithelial mast cell count. Secondary endpoints include evaluating the reduction of dysphagia symptoms, eosinophil infiltration, and the assessment of safety. The study will involve approximately 60 clinical trial centers across 8 countries.

EoE is the most common form of eosinophilic gastrointestinal disease, characterized by eosinophil infiltration in the esophagus. The chronic inflammation associated with EoE can lead to difficulties in swallowing, chest pain, vomiting, and food impaction, which can be a medical emergency. Current treatment options for EoE are limited. Given the lack of effective therapies and the potential of barzolvolimab as a mast cell depleting agent, Celldex Therapeutics considers the study of EoE to be of great importance. For additional information on this trial (NCT05774184), please visit www.clinicaltrials.gov.

Barzolvolimab is a humanized monoclonal antibody that specifically binds to the receptor tyrosine kinase KIT, inhibiting its activity. KIT is expressed in various cell types, including mast cells, which play a role in inflammatory responses and allergic reactions. By targeting KIT signaling, barzolvolimab aims to regulate mast cell differentiation, tissue recruitment, survival, and activity. Inflammatory diseases where mast cell activation is central, such as chronic urticaria, may also benefit from this mechanism of action.

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