Realm Therapeutics has dosed the first patient in its Phase ll trial of PR022 for the treatment of atopic dermatitis, a serious form of eczema.
The randomised, double-blind, vehicle-controlled, multicentre, parallel-group study is currently being conducted in the US.
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The trial will evaluate the safety and efficacy of multiple doses of PR022 in around 120 adult patients with mild-to-moderate atopic dermatitis.
Various endpoints will be evaluated in the trial such as Eczema Area and Severity Index (EASI) and investigator global assessment (IGA), as well as additional tests of pruritus and quality of life. Results are expected by the third quarter of next year.
Realm Therapeutics CEO Alex Martin said: “Recently published peer-reviewed research has demonstrated PR022’s ability to prevent the development of atopic dermatitis-like lesions, reduce existing lesions and associated scratching, and reduce the inflammatory response.”
PR022 is a topical gel formulation that contains high concentration of hypochlorous acid.
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By GlobalDataThe gel could be an alternative for patients suffering from atopic dermatitis, which is a chronic, relapsing, inflammatory disease characterised by itchy, inflamed skin.
Patients with atopic dermatitis suffer from impaired function of their skin barrier. Combined with skin damage due to intense itching and scratching related to the disease, this puts them at-risk for secondary infections due to colonisation with pathogenic bacteria.
The disease is estimated to affect up to 20% of children and up to 3% of adults.
