Business
Celldex Therapeutics Initiates Phase 1b Study of CDX-0159 in Chronic Spontaneous Urticaria
HAMPTON, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that enrollment has opened and the first patient has
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"HAMPTON, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that enrollment has opened and the first patient has been dosed in its randomized, double-blind Phase 1b study of CDX-0159 in patients with chronic spontaneous urticaria (CSU). CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. As previously presented, CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation in a Phase 1a single dose, healthy volunteer study.\n “We believe the profound decreases in plasma tryptase demonstrated in our Phase 1a study suggest CDX-0159 has significant potential as a disease-modifying therapeutic for mast cell driven disorders,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “This latest study will build on prior results as we seek to establish the safety and potential clinical benefit of multi-dosing in a disease setting fundamentally driven by mast cells—CSU. In the coming weeks, we will further expand these efforts, initiating a second Phase 1b study in chronic inducible urticaria.” The Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of CDX-0159 in patients with CSU who remain symptomatic despite treatment with antihistamines. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including measurement of tryptase and stem cell factor levels and clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response) as well as quality of life assessments. The study is expected to enroll approximately 40 patients with CSU across four cohorts (8 CDX-0159; 2 placebo). CDX-0159 dosing for each cohort is as follows: Cohort 1 - 0.5 mg/kg Q 4 weeks;Cohort 2 - 1.5 mg/kg Q 4 weeks;Cohort 3 – 3 mg/kg Q 8 weeks; and,Cohort 4 – 4.5 mg/kg Q 8...