Realm Therapeutics announced the first patient has been dosed in its phase 2 study of PR013, the company's topical ophthalmic formulation of high concentration hypochlorous acid, for the treatment of allergic conjunctivitis. The study is being conducted in the United States and top line data is expected in Q2 2018.
The study is a multicenter, double-blind, randomized evaluation of the effectiveness of PR013 topical ophthalmic solution compared to vehicle for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC) in approximately 90 patients. The Ora-CAC model has been the accepted standard for the successful development of novel treatments for allergic conjunctivitis in the U.S. for the past three decades.
"With the initiation of our second phase 2 study in as many weeks, we continue to build out our immunomodulatory pipeline and move one step closer to bringing new treatments to patients" Alex Martin, Chief Executive Officer of Realm, said in a company news release. "Allergic conjunctivitis affects up to 40% of the U.S. population but the current standards of care, steroids and anti-histamines, have significant safety and efficacy shortcomings for patients. In preclinical models, PR013 has demonstrated similar efficacy to high-dose steroids in reducing the redness associated with allergic conjunctivitis, and in reducing itch from both histaminergic and non-histaminergic pathways. Harnessing Realm's proprietary high concentrations of hypochlorous acid, PR013 has the potential to be a novel, safe and effective treatment alternative for patients suffering from allergic conjunctivitis. We look forward to the results of this study in the second quarter of next year."