Policy & Regulation
Vanda Pharmaceuticals reveals results from Phase III Tradipitant clinical trial
26 February 2020 -

United States-based Vanda Pharmaceuticals Inc (Nasdaq:VNDA) has revealed results from a Phase III EPIONE clinical trial of Tradipitant intended for the treatment of pruritus in atopic dermatitis in adults, it was reported on Tuesday.

The study did not meet its primary endpoint in decrease of pruritus across the overall study population. It was continued to showcase that Tradipitant is safe and well-tolerated. It was a randomised, placebo-controlled Phase III study (n=341) in atopic dermatitis patients with severe pruritus with a range of disease severity presentation from mild (23%) to moderate (64%) and severe (13%t) as determined by the Investigator's Global Assessment scale. Results from the study and scientific literature indicate that mild and severe atopic dermatitis appear to be distinct endotypes with different sets of causative factors and course.

Dr Sonja Stander, professor of Dermatology and Neurodermatology at the Department of Dermatology, and head of the Interdisciplinary Center for Chronic Pruritus (KCP) of the University Hospital Münster, Germany, said, 'The majority of AD patients across all age groups from children to seniors suffer from a form of atopic dermatitis characterised by mild lesions. Yet these patients might still have severe pruritus and suffer from impacts to quality of life, as well as sleep. With a beneficial safety profile and assuming this significant improvement in itch in the mild-type atopic dermatitis is confirmed in a future study, this therapy would be of interest to all these mild-type AD patients.'

The results of the EPIONE study will need to be confirmed in a follow up study. Vanda plans to reassess the ongoing EPIONE2 study of pruritus in AD as it continues to analyze the results and determines next steps.

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