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- Study met primary endpoint demonstrating barzolvolimab's ability to potently deplete mast cells in the gastrointestinal tract
- Profound mast cell depletion did not result in improved clinical outcomes providing direct evidence that mast cells are not a primary driver in EoE
- Favorable safety profile demonstrated for barzolvolimab 300 mg Q4 weekly dosing regimen
- Company to host webcast today at 4:30 pm ET
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported topline results from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. Identifying the key drivers of EoE has challenged the field and research has suggested that mast cells could play an important role in the disease pathogenesis. Celldex designed this study to determine if barzolvolimab could deplete mucosal (intraepithelial) mast cells and, in turn, improve clinical outcomes in EoE. The primary endpoint of the study, absolute change from baseline to Week 12 in peak esophageal intraepithelial mast cell count was met, but the profound mast cell depletion observed did not result in improvement in EoE symptoms or endoscopic assessment of disease activity compared to placebo. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile. Based on these results, Celldex will not advance development in EoE. The results do support future development with KIT- or SCF-targeted therapies in other GI indications where mucosal mast cells are believed to play an important role.
"As we explore barzolvolimab's full potential as a mast cell depleting agent, we are ultimately defining which diseases are mast cell driven," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "While we are disappointed in the clinical outcome in EoE, we are proud of our role in advancing the science for patients who need more effective treatment options."
"We remain focused on advancing the deep pipeline for barzolvolimab, with enrollment ongoing across four studies, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis, while we also finalize plans to initiate a Phase 3 program in inducible urticaria that will include both cold urticaria and symptomatic dermographism," continued Marucci. "We are deeply committed to driving innovation in mast cell science and delivering life-changing therapies for patients and look forward to advancing barzolvolimab and our growing pipeline of KIT- and SCF-targeting candidates into additional indications in the future."
Summary of Key Findings
- Profound reduction in CD117+(KIT) and tryptase+ intraepithelial mast cells
- Primary endpoint met with high statistical significance. Peak mast cell counts (CD117 positive cells) per high power field (hpf) at baseline were 50.3 in the placebo arm and 55.4 in the barzolvolimab 300mg Q4W arm. At Week 12 the absolute change from baseline was -2.7 for placebo compared to -36.0 for barzolvolimab
