Realm Therapeutics Submits Investigational New Drug Application for PR022 for Atopic Dermatitis

Realm Therapeutics plc submitted its first investigational new drug (IND) application to the FDA for PR022 as a novel treatment for atopic dermatitis (AD).  Pending acceptance, the IND will enable Realm to initiate a Phase 2a proof-of-concept trial for patients with atopic dermatitis.
 
The Phase 2a trial will be a randomized, double-blind, vehicle-controlled, multicentre, parallel-group study to assess the safety and efficacy of multiple doses of PR022 in adult patients with mild-to-moderate AD.  Based on outcomes of this study, the company says it intends to conduct a Phase 2b study to include adolescent patients with the goal to incorporate paediatric patients in their pivotal Phase 3 trials.
 
PR022 is a proprietary, non-alcohol based, topical gel, in which the active moiety is a patented high concentration of hypochlorous acid, offering a differentiated mechanism of action for the treatment of a significant disease.  The company has demonstrated that PR022 is associated with a statistically significant therapeutic effect in animal models of atopic dermatitis, including down modulation of key pro-inflammatory cytokines and reduced expression of Th2 cytokines, IL-4, IL-13 and IL-31, as well as TARC and TSLP, which are all linked to the signs and symptoms of the disease.  Importantly, these results are delivered without the typical negative effects of commonly used AD immunomodulatory or immunosuppressant drugs, including corticosteroids, suggesting an advantageous safety profile for PR022.