Celldex Therapeutics Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022
-Rapid, profound and durable responses across multiple dosing groups with favorable safety profile-
HAMPTON, N.J., June 30, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced interim data from the Company’s ongoing Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. 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.
Data show that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over 7 days (UAS7), with a mean UAS7 reduction of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the ongoing 3.0 mg/kg dose group (n=9) at week 8 (reflects one dose), demonstrating meaningful symptom improvements for patients. Complete response as measured by UAS7=0 was 57.1% for patients in the 1.5 mg/kg dose group at week 12 and 44.4% for the patients in the 3.0 mg/kg dose group at week 8 (reflects one dose; ongoing).
Importantly, administering multiple doses of barzolvolimab demonstrated a favorable safety profile, supporting Phase 2 clinical development. These data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, as a late-breaking electronic poster presentation (#100097) as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2022.
“We are excited by these interim multiple dose data which demonstrate strong clinical activity, rapid onset and sustained durability with a well-tolerated safety profile, including in patients with prior omalizumab experience,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. “We believe these impressive early data further demonstrate barzolvolimab’s unique mechanism and its potential to provide meaningful symptom relief to patients suffering from diseases driven by mast cells. These data support the continued development of barzolvolimab, including our recently initiated Phase 2 chronic urticaria studies.”
“These remarkable early results confirm that chronic urticaria is driven by mast cells and barzolvolimab has again demonstrated its ability to bring meaningful improvements to patients suffering from these often very severe and debilitating diseases,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin and a lead investigator on the study. “There are extensive numbers of patients globally with CSU who cannot be helped at all with the current standard of care, so barzolvolimab would represent a considerable advance in the treatment landscape for these patients and potentially other diseases with mast cell involvement.”
Summary of Data from Ongoing Phase 1b CSU Trial of Barzolvolimab
As of the data cut-off on May 23, 2022, 34 patients with CSU were enrolled and treated [26 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg) and 8 placebo]. The 0.5 mg/kg and 1.5 mg/kg cohorts had completed study participation through 24 weeks; 7 of 12 patients in the 3.0 mg/kg cohort had completed week 12; enrollment in the 4.5 mg/kg cohort was ongoing. Adverse events through data cutoff and hematology data through week 12 were included for all dose groups; clinical activity and tryptase data were included through week 12 for 0.5 mg/kg and 1.5 mg/kg, and through week 8 for 3 mg/kg (ongoing; reflecting the administration of only one dose).
Interim Clinical Activity Results
Summary of Clinical Activity Assessments at week 12 for 0.5 mg/kg and 1.5 mg/kg dose groups and week 8 for 3.0 mg/kg dose group (ongoing, clinical activity reflects one dose):
The UAS7 score is calculated as the sum over 7?days of the daily intensity of itch (ISS7 itch severity score) and number of hives (HSS7 hives severity score). UAS7 values range from 0 to 42, with higher values reflecting higher disease activity. UCT has 4 items with 5 answer options (scored with 0-4 points); recall period of 4 weeks. Low points indicate high disease activity and low disease control. The minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control and =12 indicating well controlled disease.
The Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of barzolvolimab in patients with moderate to severe 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 barzolvolimab; 2 placebo). Barzolvolimab is administered intravenously at 0.5 mg/kg mg every 4 weeks, 1.5 mg/kg every 4 weeks, 3 mg/kg every 8 weeks, 4.5 mg/kg every 8 weeks, as add-on treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists. For additional information on this trial (NCT04538794), please visit www.clinicaltrials.gov.
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