Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—temperatures below skin temperature in ColdU and scratching/rubbing of the skin in SD.
This morning’s news release said mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. In February 2024, the Company presented positive 12-week primary endpoint results from its ongoing Phase 2 study of barzolvolimab in the most common form of chronic urticaria—chronic spontaneous urticaria (CSU).
“We are very grateful to all the investigators and patients who supported this trial,” said CEO Anthony Marucci. “While individuals with inducible urticaria go to great lengths to avoid disease triggers in their daily lives, many find it impossible to do so and are severely burdened by this disease.”
CLDX shares grabbed 25 cents to $38.84.
