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-controlled study evaluated 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 ongoing EPIONE 2 study 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.”
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