Realm Therapeutics announced the first patient has been dosed in its phase 2 study of PR022, the company's proprietary topical gel formulation of high concentration hypochlorous acid, for the treatment of atopic dermatitis. The trial is being conducted in the United States and top line data is expected in Q3 2018.
The phase 2 study is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study assessing the safety and efficacy of multiple doses of PR022 in approximately 120 adult patients with mild-to-moderate atopic dermatitis. Multiple endpoints will be explored, including EASI1 and IGA2, as well as additional assessments of pruritus and quality of life.
"We are extremely pleased to have initiated our first phase 2 study, which represents a significant milestone for Realm as we continue to execute on our strategy," Alex Martin, Chief Executive Officer of Realm, said in a company news release. "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 could offer an important alternative to patients suffering from atopic dermatitis and we are very excited about the potential of this new therapy."
1Eczema Area and Severity Index (EASI) is an investigator-assessed tool used to measure the extent (area) and severity of atopic eczema.
2 Investigator Global Assessment (IGA), is an investigator-assessed instrument measuring severity of atopic dermatitis on a 5 grade scale.