Realm Therapeutics is set to initiate a Phase II clinical trial of PR013 to treat allergic conjunctivitis (AC), following approval of its investigational new drug (IND) application by the US Food and Drug Administration (FDA).
PR013 belongs to a new class of anti-inflammatory / immunomodulatory drugs that utilise a high concentration of hypochlorous acid as the active ingredient.
The multi-centre, double-blind, randomised Phase II trial will assess the effectiveness of topical ophthalmic drops of PR013 compared to vehicle.
Designed to enrol around 90 patients in the US, the trial will use a modified conjunctival allergen challenge model (Ora-CAC), which is the accepted standard for the successful development of new AC treatments in the country.
Realm Therapeutics CEO Alex Martin said: “The product represents a promising novel therapeutic approach for treating adults and children with allergic conjunctivitis.
“There is a significant unmet medical need in AC, particularly for the circa 30% of patients who are refractive to the standard of care, antihistamines, and due to the significant safety concerns with steroid treatments, including increased intraocular pressure, which can lead to glaucoma.”
Intended to act as a safe and effective alternative to existing therapies, PR013 is reported to have shown an efficacy similar to high-dose steroids in pre-clinical models.
Realm Therapeutics previously obtained approval for another Phase II trial of PR022 for the treatment of atopic dermatitis (AD).
The firm intends to commence both trials by the end of this year and plans to report top-line results by mid next year.