Vanda Pharmaceuticals announced data from the phase 3 EPIONE study of tradipitant for the treatment of pruritus in atopic dermatitis.
The 8-week, multicenter, double-blind, placebo-controlledstudyevaluated the efficacy of tradipitant, a neurokinin-1 receptor antagonist, in 341 adult patients with atopic dermatitis who presented with severe pruritus. Patients were randomized 1:1 to receive either tradipitant 85mg twice daily or placebo for 8 weeks. The primary end point was the reduction of worst itch in atopic dermatitis, as measured by the Worst Itch-Numerical Rating Scale (WI-NRS).
Results showed that tradipitant did not meet the primary end point in the overall population despite demonstrating greater improvements in pruritus compared with placebo. Study findings suggested a significant correlation between baseline disease severity (IGA 1-4) and treatment effect (P=.0004).
When baseline disease severity and treatment were taken into account, tradipitant demonstrated a greater improvement in WI-NRS at the pre-specified end point of week 8 in the full trial population (P=.0217). Patients with mild disease severity showed the largest improvement compared with placebo at every visit. A clinically meaningful response was observed in 72.5% of tradipitant-treated patients vs 33.3% of placebo patients based on the categorical WI-NRS responder analysis (>4 points improvement).
The Company will further evaluate the data from EPIONE in a follow up study. Additionally, the Company will reassess tradipitant in the ongoingEPIONE 2study of pruritus in atopic dermatitis.
“Although we are disappointed that EPIONE did not meet its primary end point, the profile of efficacy demonstrated in this study potentially addresses a highly unmet need of treating intractable pruritus for a large portion of AD patients,” said Mihael H. Polymeropoulos, MD, CEO of Vanda. “The safe profile of tradipitant, coupled with a significant and immediate onset of itch reduction by the first full day of treatment, may provide a much-needed therapy for the majority of AD patients that experience mild AD lesion severity but still suffer from significant pruritus.”
