Experimental treatment eases chronic itching, hives in clinical trials
Barzolvolimab outperforms placebo in patients with CSU and angioedema
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The experimental therapy barzolvolimab can reduce disease activity in people with chronic spontaneous urticaria (CSU) — an inflammatory disorder characterized by recurrent itching and hives — who experience angioedema, according to results from two Phase 3 clinical trials.
Celldex Therapeutics, the company developing barzolvolimab, plans to use the data to apply for U.S. approval of barzolvolimab for CSU. The company said it expects to submit an application in 2027.
“We are proud of the results shared today and believe that barzolvolimab has the potential to address the enormous unmet need in CSU,” Diane Young, MD, senior vice president and chief medical officer of Celldex, said in a company press release. “Barzolvolimab continued to show unprecedented complete response rates across the overall studies and demonstrated strong differentiation in patient populations underserved by existing therapies, including those with severe disease or angioedema.”
The company believes barzolvolimab “can be a transformational therapy for people living with CSU,” Young said.
Some people with CSU experience angioedema, which refers to swelling under the skin or in the mucus membranes. Antihistamines, the mainstay treatment for CSU, have limited ability to control angioedema.
Antibody-based treatment
Barzolvolimab is an antibody-based therapy designed to block the activity of mast cells, a type of immune cell with a central role in driving CSU, easing angioedema symptoms. The therapy is given by subcutaneous (under-the-skin) injection.
Following positive results from a Phase 2 trial (NCT05368285), Celldex sponsored a pair of Phase 3 trials to further evaluate the therapy in people with CSU whose disease was not adequately controlled with standard antihistamines.
The trials, EMBARQ-CSU1 (NCT06445023) and EMBARQ-CSU2 (NCT06455202), collectively enrolled nearly 2,000 patients. Some participants were treated with barzolvolimab at an initial dose of 300 mg, followed by 150 mg every four weeks. Others received an initial dose of 450 mg, followed by 300 mg every eight weeks. The remaining participants were given a placebo.
In both studies, the main goal was to determine whether barzolvolimab was superior to a placebo in lowering UAS7 scores — a standard measure of symptom severity in CSU, with lower scores representing less severe symptoms — after 12 weeks. Results showed that, in both studies, scores for patients given a placebo improved by an average of about 10 points after 12 weeks. Patients given either regimen of barzolvolimab improved significantly more — about 20 points on average in both trials.
Barzolvolimab also outperformed the placebo in the proportion of patients who achieved a score of 0 on the UAS7, indicating no CSU symptoms. After 12 weeks in both studies, about one in 10 patients given placebo achieved a score of 0, compared with more than four out of 10 patients given barzolvolimab. Similar differences were seen at 24 weeks of follow-up, at which point roughly half of patients on barzolvolimab had a score of 0, compared with about one in seven on placebo.
Celldex said barzolvolimab also outperformed a placebo across various subgroups, including patients with angioedema, those with severe disease, and those whose disease had not responded to the approved medication Xolair (omalizumab). Safety data were consistent with earlier studies, the company said.
“The results from our two Phase 3 EMBARQ-CSU trials showed efficacy that is best-in-disease in CSU,” said Anthony Marucci, the company’s co-founder, president, and CEO. “We believe barzolvolimab is well-positioned to address large CSU populations of high unmet need—as a first-line therapy for patients with severe CSU or angioedema, and as the second-line advanced therapy of choice.”
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