Atopix Therapeutics Ltd has announced the recruitment of the first patient in a six month Phase 2 clinical trial of its lead compound OC459 in moderate-to-severe atopic dermatitis (eczema).
OC459 is designed as a once daily oral treatment. The first patient in this randomized, double-blind, placebo-controlled study was dosed at the University of Sheffield Medical Centre, United Kingdom.
The clinical study is funded by a grant from the Biomedical Catalyst fund and incorporates other leading dermatology centres in the UK, Germany, Austria, France and Finland which will initiate dosing shortly.
The study aims to detect an effect of OC459 on flares, the major health economic burden in atopic dermatitis. The primary endpoint of the study will be judged against the Eczema Activity Severity Index (EASI), a score which measures the extent and severity of atopic dermatitis.
Genetic variants in CRTH2 predispose patients to the development of atopic dermatitis. As a CRTH2 antagonist, OC459 has demonstrated in pre-clinical studies that it suppresses the recruitment and production of key cells that mediate an allergic response such as Th2 lymphocytes, basophils and eosinophils, resulting in reduced disease pathology.
It is anticipated that patients with a highly atopic Th2 dominant form of eczema, who typically have a more severe form of the disease and are prone to flares, will benefit from treatment with OC459.
Mark Payton, CEO of Atopix, said: “Recruitment of the first patient to this study is a key milestone in the development of OC459 for the treatment of moderate to severe atopic dermatitis. Our partnership with some of the leading dermatology investigators in the European Union demonstrates our shared belief that the suppression of Th2-mediated allergic responses following dosing with OC459 will benefit patients with this severe allergic disease. With approximately 3.2% of the US and EU population and 15-20% of children affected by atopic dermatitis, new treatments to effectively control the debilitating symptoms and intervene in disease progression are urgently required.”