Realm Therapeutics has submitted its first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for PR022, as a novel treatment for atopic dermatitis (AD).
If FDA approves application, Realm will initiate a Phase 2a proof-of-concept trial for patients with atopic dermatitis. Phase 2a trial will include adult patients with mild-to-moderate AD and based on the outcomes, the company will also include adolescent patients with the goal to incorporate paediatric patients in their pivotal Phase 3 trials, said the company.
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 AD.