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.
Neurocrine Biosciences announces presentation of Osavampator Phase 2 data at Psych Congress 2025
Ascletis presents ASC30 study results at EASD Annual Meeting
Three WuXi Biologics manufacturing facilities receive GMP certification from Turkish regulator
VarmX secures strategic collaboration and option agreement with CSL for novel coagulation therapy
Avidity Biosciences closes USD690m public offering of common stock
Akeso's ligufalimab (CD47 mAb) granted FDA Orphan Drug Designation for AML
Forte Biosciences highlights positive FB102 data in celiac disease at Tampere Symposium
SureSpace Launches in Dubai to Tackle Doomscrolling and Redefine Social Networking
Kodiak reports positive APEX data for KSI-101 in macular edema secondary to inflammation
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial
Phrontline Biopharma doses first patient in TJ101 Phase 1 clinical trial
Gene Solutions' mitochondrial therapy platform targeting neurological diseases secures patent
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Avidity Biosciences prices upsized common stock public offering