Vanda reports results from Phase II clinical study of tradipitant
Vanda Pharmaceuticals announced results from an 8-week randomized Phase II clinical study of tradipitant as a monotherapy in the treatment of chronic pruritus in patients with atopic dermatitis. Tradipitant was shown to improve the intensity of the worst itch patients experienced, as well as atopic dermatitis disease severity. Tradipitant demonstrated significant and clinically meaningful improvement in a number of measures of itch. Specifically, significant improvements were observed in the measurement of Worst Itch Visual Analog Scale (p=0.019). Tradipitant also showed significant effects in a responder analysis for Worst Itch in patients who achieved improvements of greater than or equal to 40 points improvement from baseline in Worst Itch VAS scores (p=0.037) or greater than or equal to 30 points (p=0.049). On the pre-specified primary endpoint of Average Itch VAS, tradipitant showed improvement over placebo, but this improvement was not significant due to high placebo effect and the lack of sensitivity of this measure. Consistent with the observed improvements in Worst Itch, which is associated with scratching behavior, tradipitant also demonstrated disease modifying properties by showing significant improvement in the Total SCORAD scale (p=0.008) and Objective SCORAD scale (p=0.005). Specifically, tradipitant showed significant improvements in several clinical features of severity of atopic dermatitis, including excoriation, erythema, oozing and dryness.