Celldex's barzolvolimab clears late-stage urticaria trials

Celldex Therapeutics announced on Tuesday that its investigational drug barzolvolimab met the primary and secondary endpoints in two late-stage trials for chronic spontaneous urticaria, a condition characterised by recurrent hives and swelling that is not adequately controlled by standard allergy medications.

The two trials together enrolled 1,939 patients and evaluated two dose levels of barzolvolimab against a placebo. At 12 weeks, both doses produced a statistically significant reduction in disease activity compared with placebo.

Complete response rates — defined as no itching or hives — ranged from about 42.1% to 45.7% among patients receiving barzolvolimab at week 12, against roughly 9.3% to 12.6% for those on placebo. The benefit was either maintained or improved through week 24, when complete response rates climbed to between 45.1% and 54% in the treatment arms, compared with about 15% to 18% in the placebo group.

The drug also demonstrated efficacy in patients whose disease had not responded to omalizumab, marketed as Xolair by Novartis and Roche, as well as in patients with angioedema.

Treatment in both trials is set to continue through 52 weeks. Celldex intends to submit a marketing application to the US Food and Drug Administration in 2027.

Separately, in July the company discontinued development of barzolvolimab for prurigo nodularis after the drug failed to meet the main and key secondary goals in a mid-stage study.