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Celldex Successfully Completes Enrollment for Phase 2 Study Investigating Barzolvolimab in Patients with Chronic Spontaneous Urticaria

Wednesday, July 12, 2023

Celldex Therapeutics, a biopharmaceutical company, has announced the successful completion of patient enrollment for its Phase 2 clinical study evaluating the effectiveness of barzolvolimab in treating chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody designed to target and inhibit the activity of the receptor tyrosine kinase KIT, which is crucial for mast cell function and survival. CSU is a condition characterized by persistent hives or wheals lasting for six weeks or more without identifiable triggers.

Currently, treatment options for CSU patients are limited, particularly for those who do not respond to omalizumab. Recognizing the high unmet need, Celldex Therapeutics believes that barzolvolimab holds significant promise as a potential new treatment option for chronic urticaria patients. The completion of patient enrollment ahead of schedule is a noteworthy achievement for the study.

Anthony Marucci, the President and CEO of Celldex Therapeutics, expressed gratitude to the investigators and patients involved in the trial, acknowledging their support. He emphasized the seriousness and impact of CSU on patients' quality of life and highlighted the urgent need for new treatment options. The company aims to present the topline data from the Phase 2 study before the end of this year.

The Phase 2 study is a randomized, double-blind, placebo-controlled trial that aims to assess the efficacy and safety profile of different dose regimens of barzolvolimab in CSU patients who remain symptomatic despite antihistamine therapy. The study exceeded its enrollment projections, with 208 patients being randomly assigned to receive subcutaneous injections of barzolvolimab at different doses (75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks) or placebo during the 16-week placebo-controlled treatment phase.

Following the initial treatment phase, patients will enter a 36-week active treatment phase. Patients not previously assigned to the 150 mg or 300 mg dose regimens will be randomized to receive one of these options in a 1:1 ratio, while those already assigned to these treatment arms will continue with the same regimen. A follow-up phase of 24 weeks will follow the 52-week mark. The study's primary endpoint is the mean change from baseline to Week 12 in UAS7, with secondary endpoints including safety assessments and evaluations of clinical activity using ISS7, HSS7, and AAS7.

Chronic Spontaneous Urticaria (CSU) is a condition characterized by the presence of hives or wheals that persist for six weeks or longer without any identifiable triggers or causes. It is caused by the activation of mast cells in the skin, leading to the release of histamines, leukotrienes, and chemokines. This results in episodes of itchy hives, swelling, and inflammation of the skin, which can last for years or even decades. Current treatment options for CSU only provide symptomatic relief for some patients.

Barzolvolimab is a humanized monoclonal antibody that specifically targets and inhibits the activity of the receptor tyrosine kinase KIT. KIT is expressed in various cell types, including mast cells, which play a crucial role in mediating inflammatory responses, hypersensitivity, and allergic reactions. Mast cell activation is central to the development and progression of inflammatory diseases like chronic urticaria.

By selectively binding to KIT and inhibiting its activity, Barzolvolimab aims to modulate mast cell function. This holds the potential to address the underlying mechanisms of chronic urticaria and offer a new therapeutic approach for patients. By reducing mast cell activation, Barzolvolimab may alleviate the symptoms associated with CSU and provide a more effective treatment option for patients suffering from this condition.

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