Realm Therapeutics asks FDA’s approval for its first IND for atopic dermatitis treatmentJanuary 30, 2017
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.