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

By Reuters News

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.

Capital.com is an execution-only brokerage platform and the content provided on the Capital.com website is intended for informational purposes only and should not be regarded as an offer to sell or a solicitation of an offer to buy the products or securities to which it applies. No representation or warranty is given as to the accuracy or completeness of the information provided.

The information provided does not constitute investment advice nor take into account the individual financial circumstances or objectives of any investor. Any information that may be provided relating to past performance is not a reliable indicator of future results or performance.

To the extent permitted by law, in no event shall Capital.com (or any affiliate or employee) have any liability for any loss arising from the use of the information provided. Any person acting on the information does so entirely at their own risk.

Any information which could be construed as “investment research” has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such is considered to be a marketing communication.