Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that an abstract describing 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024 being held in Washington, DC on February 23-26, 2024. Abstracts will be available on the meeting website today, February 5, 2024.
Presentation details are below:
Abstract Title: Barzolvolimab Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial
Presenting Author: Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin
Session: Late Breaking Oral Abstract Session
Date/Time: Saturday, February 24 at 2:05 pm – 2:15 pm ET
The abstract is comprised of the topline 12-week primary endpoint results the Company disclosed on November 6, 2023.
The Phase 2 randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CSU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 208 patients were randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment period. After 16 weeks, patients then enter a 36-week active treatment period, in which patients not already randomized to barzolvolimab at 150 mg every 4 weeks or 300 mg every 8 weeks are randomized 1:1 to receive one of these two dose regimens; patients already randomized to these treatment arms remain on the same regimen as during the placebo-controlled treatment period. After 52 weeks, patients then enter a follow-up period for an additional 24 weeks. The primary endpoint of the study is mean change in baseline to Week 12 in UAS7. Secondary endpoints include other assessments of safety and clinical activity including ISS7, HSS7 and AAS7.
Webcast and Conference Call
The Company will host a webcast presentation of the data on Sunday, February 25th at 9:45 AM ET. The event will be webcast live and can be accessed by going to the “Events & Presentations” page under the “Investors & Media” section of the Celldex Therapeutics website at www.celldex.com.
