Celldex's skin disease drug meets goals in two late-stage trials

Sept. 22 (Reuters) - Celldex Therapeutics CLDX.O said on Tuesday its experimental drug for a skin disease met the main and secondary goals of two late-stage trials.

Here are the details:

• The company is testing barzolvolimab in patients with chronic spontaneous urticaria — a condition that causes recurring hives and swelling — whose symptoms are not adequately controlled by allergy medicines.
• The two late-stage trials enrolled a combined 1,939 patients and tested two doses of barzolvolimab against a placebo.
• At 12 weeks, both doses of the drug significantly reduced disease activity compared with placebo.
• About 42.1% to 45.7% of patients treated with barzolvolimab had a complete response at week 12, meaning they had no itching or hives, compared with about 9.3% to 12.6% of those on placebo.
• The benefit was sustained or improved through week 24, when complete response rates ranged from about 45.1% to 54% among patients receiving barzolvolimab, versus about 15% to 18% for placebo.
• The drug also showed a benefit in patients whose disease had not responded to omalizumab, sold as Xolair by Novartis NOVN.S and Roche ROPC.S, and in patients with angioedema.
• Treatment in both trials will continue through 52 weeks, and Celldex plans to submit a marketing application to the US Food and Drug Administration in 2027.
• In July, Celldex Therapeutics discontinued development of barzolvolimab for patients with prurigo nodularis after it failed to meet the main and key secondary goals in a mid-stage study.