Celldex said its monoclonal antibody has shown encouraging efficacy in a mid-stage trial in patients with an inflammatory skin condition that features hives and swelling, setting the stage for registrational test.
In the placebo-controlled Phase 2 study of 196 people with chronic inducible urticaria (CIndU), both doses of Celldex’s barzolvolimab achieved a statistically significant improvement in the primary endpoint of percentage of patients with a negative provocation test at 12 weeks, according to a Monday company release. The test involves purposely provoking the symptoms of disease.
In patients with cold urticaria, whose symptoms are triggered by cold temperatures, the 300 mg dose administered every eight weeks saw 53.1% of 32 patients get a negative result on the provocation test (p=0.0011). As for symptomatic dermographism, where symptoms are triggered by scratching or rubbing of the skin, the 300 mg dose saw 42.4% of 33 patients get a negative result on the test (p=0.0003).
The efficacy results in both disease subtypes appear “competitive” given that there’s “limited data” in the space, Jefferies analysts wrote in a Monday note. Barzolvolimab targets the receptor tyrosine kinase KIT, which is expressed in mast cells, which in turn can mediate inflammatory responses like allergic reactions.
Yet, Celldex’s share price $CLDX dropped almost 6% to close at $41.99 on Monday.
There was one case of a barzolvolimab patient who was hospitalized for what an investigator believed was anaphylaxis. But that person was treated and recovered within days, and it was concluded there was no evidence of anaphylaxis. The Jefferies analysts wrote they were not too concerned by anaphylaxis given the low incidence rate so far and the low likelihood of the need for a black box warning.
Overall, barzolvolimab was well tolerated with the most common side effects being changes in hair color (13%) and neutropenia (11%).
Celldex said it will present the full 12-week data at a medical meeting in the fourth quarter of the year. The company is planning to advance barzolvolimab into Phase 3 development in CIndU, with details of trial design to be hashed out with the FDA at an end-of-Phase 2 meeting.