Abingdon, UK – 19 November 2013 – Atopix Therapeutics Ltd (“Atopix”), a biopharmaceutical company developing innovative CRTH2 antagonists for allergic disease, today 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 randomised, double-blind, placebo-controlled study was dosed today 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.”
Notes To Editors
About Atopix Therapeutics Ltd
Atopix Therapeutics Limited is a privately held, clinical-stage, biopharmaceutical company based in Oxford, UK, with an innovative approach to allergic disease. The company is developing a novel class of oral anti-allergic medicines, called CRTH2 antagonists, to treat atopic dermatitis, asthma and allergic rhinitis. Its lead candidate is currently being studied in a Phase 2 clinical trial for moderate-to-severe atopic dermatitis in several leading European dermatology centres. Atopix has a pipeline of highly potent back-up CRTH2 antagonists, including the Phase 1 ready oral candidate ATX2417, and topical candidates that can be formulated for treatment of a number of severe allergic conditions including eye disease. For more information, please visit http://www.atopixtherapeutics.co.uk.
About Atopic Dermatitis
The increasing prevalence of allergy is a major health issue. Often manifested as atopic dermatitis in early childhood, allergies can progress to allergic rhinoconjunctivitis and severe allergic asthma. This process has been termed the “atopic march” and new treatments are badly needed to effectively control the debilitating symptoms and intervene in disease progression. An estimated 3.2% of the US and EU population have atopic dermatitis with 15-20% of children being affected. Currently, oral systemic therapy is reserved for the most severe intractable cases which receive oral steroids, methotrexate, azathioprine or cyclosporin, all of which have potentially serious side effects. The world wide market for drugs to treat atopic dermatitis is projected to be approaching £1.0bn per year by 2017.
OC459 is an orally active CRTH2 antagonist which has been shown to be effective in the treatment of eosinophilic asthma and allergic rhinoconjunctivitis. It is effective when dosed once a day and provides marked improvements in patients with a Th2 dominant eosinophilic form of disease. Such patients typically have more severe disease and are prone to exacerbations. An attractive feature of OC459 is that it can be used to treat multiple co-morbid allergic diseases simultaneously.
About the Biomedical Catalyst
The Biomedical Catalyst, announced by Prime Minister David Cameron in December 2011, is a programme of public funding designed to deliver growth to the UK life sciences sector. Delivered jointly by the Medical Research Council and the Technology Strategy Board, the Biomedical Catalyst provides responsive and effective support for the best life science opportunities arising in the UK.
The programme is open to UK academics and SMEs and seeks to support those opportunities which demonstrate the highest scientific and commercial potential, irrespective of medical area. For further information please visit: http://www.innovateuk.org/content/competition/biomedical-catalyst.ashx.
Issued for and on behalf of Atopix.
To contact the Atopix team at College Hill, email firstname.lastname@example.org.
Dr Eileen PaulAssociate Partner