Celldex Therapeutics, Inc. (NASDAQ: CLDX) has just released its topline results from the phase 2 study of barzolvolimab in treating eosinophilic esophagitis (EOE), a chronic inflammatory disease of the esophagus. The study aimed to determine if barzolvolimab could deplete mast cells in the gastrointestinal tract and subsequently improve clinical outcomes in EOE.
The study met its primary endpoint, demonstrating barzolvolimab's ability to potently deplete mast cells in the gastrointestinal tract. Specifically, the study found that the absolute change from baseline to week 12 in peak esophageal intraepithelial mast cell count was significantly reduced in patients treated with barzolvolimab compared to those on placebo. The reduction in peak mast cell counts in the barzolvolimab group was notably higher than that in the placebo group.
Despite the profound mast cell depletion observed, the study did not find any definitive evidence of clinical improvement in EOE symptoms or endoscopic assessment of disease activity when compared to the placebo group. Furthermore, there was no observed difference in histological reduction in esophageal intraepithelial infiltration of eosinophils.
The safety profile of barzolvolimab at the 300 mg q4 weekly dosing regimen was favorable, consistent with prior studies where the drug was dosed less frequently. The company conducted an unblinded review of all available data through the full treatment period (28 weeks) and the full study (44 weeks), and found that clinical and safety outcomes were consistent at these time points.
Celldex has decided not to advance the development of barzolvolimab in EOE based on these results. However, the company remains focused on advancing the deep pipeline for barzolvolimab, with ongoing enrollment across four studies, including two phase 3 studies in chronic spontaneous urticaria, and phase 2 studies in atopic dermatitis and prurigo nodularis. Additionally, plans are underway to initiate a phase 3 program in inducible urticaria that will include both cold urticaria and symptomatic dermographism.
Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase kit with high specificity and potently inhibits its activity. It is currently being studied in chronic spontaneous urticaria, two forms of chronic inducible urticaria * cold urticaria and symptomatic dermographism, prurigo nodularis, and atopic dermatitis, with additional indications planned for the future.
Today the company's shares have moved -0.89% to a price of $24.2625. For more information, read the company's full 8-K submission here.
