Celldex Therapeutics Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022 - Seite 3

All Patients	0.5 mg/kg Q4W at Week 12	1.5 mg/kg Q4W at Week 12	3.0 mg/kg Q8W at Week 8 (ongoing)	Placebo at Week 12/8
UAS7 Changes
Mean Score Change in UAS7 From Baseline	-11.1	-18.1	-22.7	-14.3 / -12.4
Mean % Change in UAS7 From Baseline	-39.7%	-66.6%	-75.1%	-35.9% / -31.1%
Clinical Responses
UAS7=0 (Complete Response)	11.1%	57.1%	44.4%	16.7% / 0%
UAS7 ≤ 6 (Well-controlled)	22.2%	57.1%	55.6%	16.7% / 0%
UCT ≥ 12 (Well-controlled)	12.5%	75.0%	83.3%	16.7% / 0%

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.

Safety Results

• Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies.
• Most AEs were mild or moderate in severity and resolved while on study, with none leading to treatment discontinuation. The most common treatment emergent adverse events were urinary tract infections, headache, neutropenia and back pain. UTIs, headache and backpain were all reported as unrelated to treatment. There was one severe adverse event of salmonella gastroenteritis which was also not related to study therapy.
• Changes in hematologic parameters were consistent with observations in single dose studies, with no pattern of further decreases with multiple doses; hematologic values generally remained within the normal range. Four patients with screening and baseline neutrophil counts at the lower end of the normal range on study initiation had decreases in neutrophil counts reported as AEs. The pattern observed in the neutrophil changes for these patients was similar to the pattern seen in patients across the barzolvolimab program to date—generally transient, asymptomatic, and mild.