Development-stage biotech Celldex Therapeutics ( NASDAQ: CLDX ) reported early-stage data to indicate that its experimental therapy barzolvolimab led to a dose-dependent effect in patients with chronic spontaneous urticaria (CSU), a disease marked by hives or wheals.
The results were based on a Phase 1b study designed to evaluate multiple ascending doses of barzolvolimab in patients with moderate to severe CSU who continue to have symptoms despite treatment with antihistamines.
While the study was expected to recruit nearly 40 patients, 34 of them had enrolled and received the therapy as of the data cut-off on May 23.
Citing interim data for a measure called urticaria activity score over 7 days (UAS7), Celldex ( CLDX ) said: “Multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives.”
The mean UAS7 reduction in the 1.5 mg/kg dose group (n=8) at week 12 and the ongoing 3.0 mg/kg dose group (n=9) at week 8 stood at ~67% and ~75%, respectively.
The complete response as indicated by UAS7=0 stood at ~57% and ~44% for the 1.5 mg/kg dose group at week 12 and 3.0 mg/kg dose group at week 8, respectively.
The safety profile for multiple doses of barzolvolimab supported its Phase 2 clinical development, the company added.
Among Wall Street analysts, Celldex ( CLDX ) commands a Strong Buy rating on average with no Sell or Hold ratings.
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Celldex posts early-stage data to support dose-dependent effect of urticaria therapy