US-based biopharmaceutical company Realm Therapeutics has submitted its first investigational new drug (IND) application for PR022 to the US Food and Drug Administration (FDA) for the treatment of patients affected with atopic dermatitis (AD).
PR022 is a non-alcohol based topical gel, in which the active moiety is a patented high concentration of hypochlorous acid that provides a differentiated mechanism of action for the treatment of a significant disease.
Once accepted by the US FDA, the IND application will allow the bio-pharmaceutical company to commence a Phase IIa proof-of-concept trial for patients suffering from AD.
Realm Therapeutics chief executive officer Alex Martin said: “The filing of the first of our two planned IND submissions in 2017 is an important milestone as Realm progresses its drug development pipeline.
“We look forward to beginning this Phase IIa study and to reviewing the subsequent data on PR022’s efficacy as a potential novel treatment for this debilitating disease.
“If successful in this and future studies, our PR022 gel will provide a safe and effective alternative to topical steroids and calcineurin inhibitors for children and adults suffering from atopic dermatitis.”
The Phase IIa trial will be carried out as a randomised, double-blind, vehicle-controlled, multi-centre, parallel-group evaluation in order to assess the safety and efficacy of multiple doses of PR022 in adult patients with mild-to-moderate AD.
AD is a form of eczema that is chronic, relapsing and inflammatory and results in itchy, inflamed skin, which significantly affects a patient’s quality of life and overall healthcare system.