UK-based biopharmaceutical firm Atopix Therapeutics has enrolled the first patient in a six-month Phase II clinical trial of its lead compound OC459, a once-daily oral treatment for patients with moderate-to-severe atopic dermatitis (AD).
Also known as atopic eczema, AD is a type of eczema, an inflammatory, relapsing, non-contagious and pruritic (itchy) skin disorder.
The dosing of the first patient was carried out at the University of Sheffield Medical Centre in the UK.
The randomised, double-blind, placebo-controlled clinical trial, which is financed by a grant from the Biomedical Catalyst fund, includes other dermatology centres in the UK, Germany, Austria, France and Finland, where dosing will start shortly.
The trial is aimed at detecting the effect of OC459 on flares, the major health economic burden in atopic dermatitis.
The trial’s primary endpoint will be judged against the Eczema Activity Severity Index (EASI), a score measuring the extent and severity of AD.
In the pre-clinical studies, OC459 has showed 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.
Treatment with OC459 is expected to benefit 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.
Atopix CEO Mark Payton said enrolment of the first patient to the trial 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," Payton said.
"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."
According to the company, genetic variants in CRTH2 predispose patients to the development of AD.
OC459 is an orally active CRTH2 antagonist that has been shown to be effective in the treatment of eosinophilic asthma and allergic rhinoconjunctivitis; it can also be used to treat multiple co-morbid allergic diseases simultaneously.
Atopix is developing a new class of oral anti-allergic medicines, called CRTH2 antagonists, to treat AD, asthma and allergic rhinitis.
Image: Atopy of the flexure crease of the elbow. Photo: courtesy of Jmh649.