On Tuesday, Celldex Therapeutics, Inc. (NASDAQ:CLDX) released topline results from its ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.
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.
Still, the profound mast cell depletion observed did not improve EoE symptoms or endoscopic assessment of disease activity compared to placebo.
Barzolvolimab demonstrated a favorable safety and tolerability profile consistent with previously reported studies.
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Based on these results, Celldex will not advance development in EoE.
“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,” said Anthony Marucci, President and CEO of Celldex Therapeutics.
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.
Mast cells defined by tryptase staining also showed profound decreases at week 12 in barzolvolimab-treated patients, with sustained and deepening decreases observed at Week 28.
Despite profound mast cell depletion, no definitive evidence of clinical improvement in EoE symptoms, as measured by the Dysphagia Symptom Questionnaire (DSQ) (p=0.33) or endoscopic scoring of EoE-related inflammation and fibrosis (EREFS) (p=0.95), was observed compared to placebo.
Researchers did not observe any significant change in the histological reduction of eosinophil infiltration in the esophageal epithelium (p = 0.57).
Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with prior studies in which it was dosed less frequently.
Price Action: At the last check on Wednesday, CLDX stock was down 11.12% to $21.35.
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