Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

- Primary and secondary endpoints met with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups -- Sustained activity with rapid onset within 2 weeks -- Similar improvement in omalizumab-experienced/refractory and omalizumab-naïve disease consistent with unique mechanism of action -- Favorable safety profile -- 52 week results and Phase 3 CSU trial initiations anticipated in 2024 -- Company to host webcast February 25th at 9:45 am ET-

HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. The studies will continue dosing patients until week 52. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who are not adequately controlled by omalizumab. The data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, in a late breaking oral presentation (L18) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024.

“These data continue to support barzolvolimab’s potential to bring meaningful improvements to patients suffering from this often very severe and debilitating disease,” said Marcus Maurer, M.D. “The novel mast cell depleting mechanism of barzolvolimab addresses the root driver of chronic spontaneous urticaria providing early, durable and, most importantly, the opportunity for complete disease control for patients who are not seeing meaningful benefits from the current standard of care, including patients with omalizumab refractory disease.”

“We are thrilled to share these positive results, which we believe further establish barzolvolimab as a potential transformative treatment option for patients suffering with CSU, and are actively planning for the initiation of our Phase 3 program in CSU this summer,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. “We also thank the patients and investigators for their participation in this study and look forward to reporting 52 week data later this year.”

Data from the 208 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels. Secondary and exploratory endpoints in the study were also achieved at week 12 and strongly support the primary endpoint results, including changes in ISS7 (weekly itch severity score) and HSS7 (weekly hives severity score) and responder analyses. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. Demographics and baseline disease characteristics were well balanced across treatment groups. The majority of patients on study had severe disease (UAS7≥28).