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Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients with Chronic Inducible Urticaria
HAMPTON, N.J., July 21, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 2
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"HAMPTON, N.J., July 21, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU) - cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals and angioedema when skin is exposed to temperatures below skin temperature. SD symptoms include the development of wheals and a flare reaction in response to stroking, scratching or rubbing of the skin. \"We are pleased that dosing has begun in this Phase 2 trial, which brings us a step closer to delivering a new treatment option to patients worldwide suffering with chronic inducible urticaria,\" said Diane C. Young, M.D., Senior Vice President and Chief Medical Officer of Celldex Therapeutics. \"Our previously reported Phase 1b data in cold urticaria and symptomatic dermographism patients demonstrated unprecedented results and we believe barzolvolimab could potentially provide meaningful change to the treatment paradigm for patients living with these severe diseases.\" The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. Approximately 180 patients in 2 cohorts (differentiated by CIndU subtype) including 90 patients with ColdU and 90 patients with SD will be randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients will then enter a follow-up phase for an additional 24 weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at Week 12 (using TempTest® for ColdU and FricTest® for SD). Secondary endpoints include safety and other assessments of clinical activity including CTT (...