193 0 Kommentare Celldex Therapeutics Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022 - Seite 2

“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

Barzolvolimab results in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
Mean reduction from baseline in urticaria activity (UAS7) 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 3.0 mg/kg dose group (n=9) at week 8 (reflects one dose; ongoing), demonstrating clinically meaningful symptom improvements for patients.
Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects one dose; ongoing) in the 3 mg/kg dose group which is a key therapeutic goal.
75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects one dose; ongoing).
Patients with prior omalizumab therapy had similar symptom improvement as all patients.
All three doses of barzolvolimab markedly improved urticaria symptoms and disease control, with rapid improvement in itch and hives. As predicted, the lowest dose of 0.5 mg/kg resulted in suboptimal clinical activity compared to the higher doses.
Rapid onset of responses after initial dosing and sustained durability were observed; onset as early as 1 week after the first dose.
Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.