Celldex Therapeutics has dosed the first patient in a Phase II study of barzolvolimab to treat eosinophilic esophagitis (EoE).

The parallel-group, placebo-controlled, double-blind, randomised study will assess the safety and efficacy of the therapeutic in patients with active EoE.

It intends to enrol around 60 patients from nearly 60 clinical trial centres across eight countries including the US.

They will be randomised into a 1:1 ratio to receive 300mg barzolvolimab subcutaneously or placebo every eight weeks, during a 16-week placebo-controlled treatment phase.

All the patients will then receive barzolvolimab 300mg every eight weeks in a 12-week active treatment phase followed by another 16 weeks.

Reducing oesophagal intraepithelial infiltration of mast cells, as assessed by peak oesophagal intraepithelial mast cell count, is the trial’s primary endpoint. 

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Safety and the reduction of symptoms of the oesophagal intraepithelial infiltration of eosinophils and dysphagia are secondary endpoints.

Celldex Therapeutics senior vice-president and chief medical officer Diane Young said: “There is a growing body of literature that suggests that eosinophilic esophagitis may be a misnomer for this difficult-to-treat disease and that other cell types, including mast cells, may play an important role in the disease process.

“This is further supported by the finding that mast cells are present in the biopsy tissue of some patients who continue to suffer from EoE even after eosinophils have been fully depleted.

“We look forward to exploring the role of our mast cell depleting agent, barzolvolimab, in this setting and believe learnings from this study may inform expanded development into other gastrointestinal (GI) disorders in the future.”

Barzolvolimab is a humanised monoclonal antibody that binds the receptor tyrosine kinase KIT and inhibits its activity.