Celldex Therapeutics Inc. (CLDX) has announced that their drug, barzolvolimab, has successfully met all primary and secondary objectives in a Phase 2 study, demonstrating significant statistical effectiveness in treating chronic inducible urticaria. This advancement highlights barzolvolimab's potential as a treatment option for this condition.
The company's Phase 2 clinical trial investigated barzolvolimab in individuals suffering from two prevalent forms of chronic inducible urticaria—cold urticaria (ColdU) and symptomatic dermographism (SD). These findings were shared during a leading oral presentation at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting held in Boston.
Celldex previously shared that barzolvolimab achieved its main efficacy goal, showing a statistically significant difference in the percentage of patients who returned negative results on provocation tests compared to a placebo at the 12-week mark. These tests comprised the TempTest for ColdU and the FricTest for SD.
Furthermore, in a follow-up announcement, Celldex reported that all secondary endpoints were achieved at the 12-week point, bolstering the primary endpoint results. These included responder analysis outcomes, enhancements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), alterations in WI-NRSprovo (itch severity related to the provocation test), and the Urticaria Control Test results.
