(RTTNews) - Celldex (CLDX) reported topline results from the Phase 2 study of Barzolvolimab in Prurigo Nodularis or PN, indicating that the study did not meet the primary endpoint and key secondary endpoints. Following the results, Celldex will discontinue the Phase 2 study in PN.

Barzolvolimab is a humanised monoclonal antibody that targets the mast cell and is being studied across multiple indications.

Prurigo Nodularis is a chronic skin disease that causes hard, intensely itchy lumps on the skin.

The Phase 2 randomised, double-blind, placebo-controlled, parallel group study evaluated barzolvolimab compared to placebo in patients with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications were medically inadvisable.

The study enrolled patients at 48 centres across six countries, including the United States.

The primary endpoint of the study was the proportion of patients who achieved a four-point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12.

Key secondary objectives included itch response at different time points, the assessment of skin lesions as measured by the Investigator Global Assessment (IGA), and safety.

The study did not meet the primary endpoint or key secondary endpoints at Week 12 at either dose level evaluated. No meaningful improvement versus placebo was observed through week 24.

Although the study failed to meet its efficacy endpoints, Celldex said that consistent with previously reported studies, barzolvolimab demonstrated a favourable safety and tolerability profile.

Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex, said "It is disappointing that this study did not confirm the promising signal we observed in the intravenous Phase 1b trial."

Also, according to Anthony, Barzolvolimab has produced "best-in-disease" data in chronic spontaneous urticaria (CSU), symptomatic dermographism, and cold urticaria, supporting the advancement of all three programs into Phase 3 studies.

Celldex looks forward to reporting clinical data from our Phase 3 CSU trials early this fall.

CLDX has traded between $19.72 and $40.30 over the last year. The stock closed Tuesday's trade at $35.66, up 0.68%.

In after-hours trading, CLDX is down 3.95% at $34.25.

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