Viaskin Peanut: Phase IIb data
Top-line data from the double-blind, international Phase IIb VIPES trial in 221 patients ages 6-55 years showed that 250 Ug Viaskin Peanut patches applied for 24 hours every 24 hours met the primary endpoint of desensitizing a greater proportion of patients to peanut at 12 months vs. placebo (50% vs. 25%, p=0.0108). High-dose Viaskin Peanut also met the secondary endpoint of increasing the mean CRD of peanut protein at 12 months vs. placebo (548.5 vs. 162.5 mg, p<0.001). In children ages 6-11 years, 250 Ug Viaskin Peanut desensitized 53.6% of patients vs. 19.4% for placebo (p=0.008) and significantly increased the mean CRD of peanut protein at 12 months vs. placebo (476.6 vs. 86.2 mg, p<0.001). In adolescents ages 12-17 years, 250 Ug Viaskin Peanut desensitized 38.9% of patients vs. 22.2% for placebo (p=not significant) and significantly increased the mean CRD of peanut protein at 12 months vs. placebo (456.9 vs. 180.9 mg, p=0.047). DBV said analysis of the adult subgroup is inconclusive due to a small sample size and high placebo effect. Data for the 50 and 100 Ug dose Viaskin Peanut patches were not disclosed. ...