RTTNews | Oct 13, 2020 08:35AM EDT

08:35 Tuesday, October 13, 2020 (RTTNews.com) - Celldex Therapeutics Inc. (CLDX) said Tuesday 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.

CDX-0159 has earlier 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.

"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. 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 cellsCSU," said Diane Young, Senior Vice President and Chief Medical Officer of Celldex Therapeutics.

Young added that to further expand these efforts, Celldex will initiate a second Phase 1b study in chronic inducible urticaria in the coming weeks.

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 as well as quality of life assessments.

The study is expected to enroll about 40 patients with CSU across four cohorts (8 CDX-0159; 2 placebo).

Celldex noted that CDX-0159 will be administered intravenously as add on treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists.

CSU is one of the most frequent dermatologic diseases, with a prevalence of 0.5 percent to 1 percent of the total population (up to 3.2 million in the U.S.). Mast cell activation drives disease through the release of histamines, leukotrienes and chemokines, resulting in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades.

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